Evidence map›Paper›PMID 33567193›Full record

Trial reportThe New England journal of medicine2021

Randomized Trial of a Vaccine Regimen to Prevent Chronic HCV Infection.

Kimberly Page, Michael T Melia, Rebecca T Veenhuis, Matthew Winter, Kimberly E Rousseau, Guido Massaccesi, William O Osburn, Michael Forman, Elaine Thomas, Karla Thornton and 17 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report 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 trial NCT01436357 (A Staged Phase I/II Study, to Assess Safety, Efficacy and Immunogenicity of a New Hepatitis C Prophylactic Vaccine Based on Sequential Use of AdCh3NSmut1 and MVA-NSmut), which is not on this map. Cited by 107 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT01436357 phase1 / phase2completednot on this map

A Staged Phase I/II Study, to Assess Safety, Efficacy and Immunogenicity of a New Hepatitis C Prophylactic Vaccine Based on Sequential Use of AdCh3NSmut1 and MVA-NSmut

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2012 to 2018Enrolled548ConditionsHepatitis CArmsAdCh3NSmut1, MVA-NSmut, Placebo
3 · Its place in the literature

Who cites it

107 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
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  11. Review
  12. Tracking Canada's 2015 vaccine research and development priorities: Where are we a decade later?Canada communicable disease report = Releve des maladies transmissibles au Canada · 2026
    Article
  13. Article
  14. Review
  15. Functional Antigen-Specific CD8 TEuropean journal of immunology · 2025
    Article
  16. Review
  17. Hepatitis C virus modifiedJournal of virology · 2025
    Article
  18. Article
  19. Article
  20. Article

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

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Kimberly PageFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Michael T MeliaFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Rebecca T VeenhuisFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Matthew WinterFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Kimberly E RousseauFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.ORCID 0000-0003-3097-0289
Guido MassaccesiFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
William O OsburnFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Michael FormanFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Elaine ThomasFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Karla ThorntonFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Katherine WagnerFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Ventzislav VassilevFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Lan LinFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Paula J LumFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Linda C GiudiceFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Ellen SteinFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Alice AsherFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Soju ChangFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Richard GormanFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Marc G GhanyFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
T Jake LiangFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Michael R WierzbickiFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Elisa ScarselliFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Alfredo NicosiaFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Antonella FolgoriFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Stefania CaponeFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.
Andrea L CoxFrom the University of New Mexico, Albuquerque (K.P., E.T., K.T., K.W.); Johns Hopkins University, Baltimore (M.T.M., R.T.V., M.W., K.E.R., G.M., W.O.O., M.F., A.L.C.), the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (S. Chang, R.G.), and the Emmes Company (M.R.W.), Rockville, and the Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda (M.G.G., T.J.L.) - all in Maryland; GSK Vaccines, Rixensart, Belgium (V.V., L.L.); the University of California, San Francisco, San Francisco (P.J.L., L.C.G., E. Stein, A.A.); the Centers for Disease Control and Prevention, Office of Policy, Planning, and Partnerships, Atlanta (A.A.); and ReiThera, Rome (E. Scarselli, A.F., S. Capone), and CEINGE, Naples (A.N.) - both in Italy.

Funding

Molecular Approaches To Vaccine Development For Hepatitis CZIADK054503 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI LIANG, T. JAKE · 2009 to 2025
$18.9M
Studies of HCV Infection, Vaccine Development and HCV-Host interactionsZIADK054504 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI LIANG, T. JAKE · 2009 to 2022
$12.0M
Scientific CoreU19AI088791 · NIAID · JOHNS HOPKINS UNIVERSITY · PI COX, ANDREA L · 2010 to 2020
$8.2M
Natural History, Therapy and Pathogenesis of Chronic Viral Hepatitis CZIADK075009 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI GHANY, MARC · 2009 to 2025
$7.2M
National Institute of Allergy and Infectious Diseases HHSN2662040074CNIAID NIH HHS HHSN266200400074CNIAID NIH HHS U19 AI088791
6 · The paper itself

Abstract

backgroundA safe and effective vaccine to prevent chronic hepatitis C virus (HCV) infection is a critical component of efforts to eliminate the disease.

methodsIn this phase 1-2 randomized, double-blind, placebo-controlled trial, we evaluated a recombinant chimpanzee adenovirus 3 vector priming vaccination followed by a recombinant modified vaccinia Ankara boost; both vaccines encode HCV nonstructural proteins. Adults who were considered to be at risk for HCV infection on the basis of a history of recent injection drug use were randomly assigned (in a 1:1 ratio) to receive vaccine or placebo on days 0 and 56. Vaccine-related serious adverse events, severe local or systemic adverse events, and laboratory adverse events were the primary safety end points. The primary efficacy end point was chronic HCV infection, defined as persistent viremia for 6 months.

resultsA total of 548 participants underwent randomization, with 274 assigned to each group. There was no significant difference in the incidence of chronic HCV infection between the groups. In the per-protocol population, chronic HCV infection developed in 14 participants in each group (hazard ratio [vaccine vs. placebo], 1.53; 95% confidence interval [CI], 0.66 to 3.55; vaccine efficacy, -53%; 95% CI, -255 to 34). In the modified intention-to-treat population, chronic HCV infection developed in 19 participants in the vaccine group and 17 in placebo group (hazard ratio, 1.66; 95% CI, 0.79 to 3.50; vaccine efficacy, -66%; 95% CI, -250 to 21). The geometric mean peak HCV RNA level after infection differed between the vaccine group and the placebo group (152.51×10

conclusionsIn this trial, the HCV vaccine regimen did not cause serious adverse events, produced HCV-specific T-cell responses, and lowered the peak HCV RNA level, but it did not prevent chronic HCV infection. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT01436357.).

Indexed as

Immunogenicity, VaccineAdenoviruses, SimianAdolescentAdultAnimalsDouble-Blind MethodFemaleGenetic VectorsHepatitis C AntibodiesHepatitis C, ChronicHumansIncidenceMaleMiddle AgedPan troglodytesSubstance Abuse, IntravenousHepatitis C AntibodiesVaccines, SyntheticViral Hepatitis Vaccines

Identifiers

PMID33567193
PMCPMC8367093

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