Evidence map›Paper›PMID 34379916›Full record

ArticleThe New England journal of medicine2021

A Monoclonal Antibody for Malaria Prevention.

Martin R Gaudinski, Nina M Berkowitz, Azza H Idris, Emily E Coates, LaSonji A Holman, Floreliz Mendoza, Ingelise J Gordon, Sarah H Plummer, Olga Trofymenko, Zonghui Hu and 29 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in The New England journal of medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 109 papers.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed
22.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04206332 phase1completednot on this map

A Phase 1, Dose Escalation, Open-Label Clinical Trial With Experimental Controlled Human Malaria Infections (CHMI) to Evaluate Safety and Protective Efficacy of an Anti-Malaria Human Monoclonal Antibody, VRC-MALMAB0100-00-AB (CIS43LS), in Healthy, Malaria-Naive Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2020 to 2022Enrolled71ConditionsMalariaArmsVRC-MALMAB0100-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
NCT05019729 phase1completednot on this map

VRC 614: A Phase 1, Dose Escalation, Open-Label Clinical Trial With Experimental Controlled Human Malaria Infections (CHMI) to Evaluate Safety and Protective Efficacy of an Anti-Malaria Human Monoclonal Antibody, VRC-MALMAB0114-00-AB (L9LS), in Healthy Malaria-Naive Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2021 to 2022Enrolled32ConditionsMalariaArmsVRC-MALMAB0114-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 149 citations in OpenAlex.

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49 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

39 authors at 1 institution in 1 country.

Martin R GaudinskiFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).ORCID 0000-0002-3743-5281
Nina M BerkowitzFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Azza H IdrisFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Emily E CoatesFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
LaSonji A HolmanFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Floreliz MendozaFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Ingelise J GordonFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Sarah H PlummerFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Olga TrofymenkoFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Zonghui HuFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Andrezza Campos ChagasFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Sarah O'ConnellFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Manjula BasappaFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Naomi DouekFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Sandeep R NarpalaFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Christopher R BarryFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Alicia T WidgeFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).ORCID 0000-0001-7615-8320
Renunda HicksFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Seemal F AwanFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Richard L WuFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Somia HickmanFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Diane WycuffFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Judy A SteinFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Christopher CaseFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Brian P EvansFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Kevin CarltonFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Jason G GallFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Sandra VazquezFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Britta FlachFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Grace L ChenFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Joseph R FrancicaFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Barbara J FlynnFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Neville K KisaluFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Edmund V CapparelliFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Adrian McDermottFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
John R MascolaFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Julie E LedgerwoodFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
Robert A SederFrom the Vaccine Research Center (M.R.G., N.M.B., A.H.I., E.E.C., L.A.H., F.M., I.J.G., S.H.P., O.T., S.O., M.B., N.D., S.R.N., C.R.B., A.T.W., R.H., S.F.A., R.L.W., S.H., D.W., J.A.S., K.C., J.G.G., S.V., B.F., G.L.C., J.R.F., B.J.F., N.K.K., A.M., J.R.M., J.E.L., R.A.S.) and the Biostatistics Research Branch, Division of Clinical Research (Z.H.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, the U.S. Public Health Service Commissioned Corps, Rockville (M.R.G.), the Entomology Branch, Walter Reed Army Institute of Research, Silver Spring (A.C.C., B.P.E.), and the Vaccine Clinical Materials Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick (C.C.) - all in Maryland; and the School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, San Diego (E.V.C.).
VRC 612 Study Team
Anna Needs Neuroblastoma Answers · US

Funding

Development of Pre-Erythrocytic Malaria Vaccines and antibodiesZIAAI005107 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI SEDER, ROBERT A · 2010 to 2025
$20.7M
Biodefense, Emerging Infectious Disease, and Malaria Monoclonal Antibody StudiesZIAAI005139 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DROPULIC, LESIA · 2019 to 2023
$12.9M
Development and Production of Anti-Malarial BiologicalsZIBAI005153 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI GALL, JASON · 2020 to 2025
$2.4M
Division of Intramural Research, National Institute of Allergy and Infectious Diseases Intramural fundsIntramural NIH HHS ZIA AI005137Intramural NIH HHS ZIA AI005138U.S. Department of Defense F0642_20_WR_CS
6 · The paper itself

Abstract

backgroundAdditional interventions are needed to reduce the morbidity and mortality caused by malaria.

methodsWe conducted a two-part, phase 1 clinical trial to assess the safety and pharmacokinetics of CIS43LS, an antimalarial monoclonal antibody with an extended half-life, and its efficacy against infection with

resultsA total of 25 participants received CIS43LS at a dose of 5 mg per kilogram of body weight, 20 mg per kilogram, or 40 mg per kilogram, and 4 of the 25 participants received a second dose (20 mg per kilogram regardless of initial dose). No safety concerns were identified. We observed dose-dependent increases in CIS43LS serum concentrations, with a half-life of 56 days. None of the 9 participants who received CIS43LS, as compared with 5 of 6 control participants who did not receive CIS43LS, had parasitemia according to polymerase-chain-reaction testing through 21 days after controlled human malaria infection. Two participants who received 40 mg per kilogram of CIS43LS and underwent controlled human malaria infection approximately 36 weeks later had no parasitemia, with serum concentrations of CIS43LS of 46 and 57 μg per milliliter at the time of controlled human malaria infection.

conclusionsAmong adults who had never had malaria infection or vaccination, administration of the long-acting monoclonal antibody CIS43LS prevented malaria after controlled infection. (Funded by the National Institute of Allergy and Infectious Diseases; VRC 612 ClinicalTrials.gov number, NCT04206332.).

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, ProtozoanAntimalarialsDose-Response Relationship, DrugHealthy VolunteersHumansInfusions, IntravenousInjections, SubcutaneousMalaria, FalciparumMiddle AgedPlasmodium falciparumAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, ProtozoanAntimalarialsCIS43LS

Identifiers

PMID34379916
PMCPMC8579034
OpenAlexW3192582034

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.