Evidence map›Paper›PMID 26706271›Full record

Trial reportVaccine2016

Rift Valley fever MP-12 vaccine Phase 2 clinical trial: Safety, immunogenicity, and genetic characterization of virus isolates.

Phillip R Pittman, Sarah L Norris, Elizabeth S Brown, Manmohan V Ranadive, Barbara A Schibly, George E Bettinger, Nandadeva Lokugamage, Lawrence Korman, John C Morrill, Clarence J Peters

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Vaccine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed
1.7field-weighted citation impact, top 16% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 58 citations in OpenAlex.

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  13. Humoral immunity to phlebovirus infection.Annals of the New York Academy of Sciences · 2023
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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

10 authors at 3 institutions in 1 country.

Phillip R PittmanU.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), 1425 Porter Street, Fort Detrick, Frederick, MD 21702-5011, United States. Electronic address: phillip.r.pittman.civ@mail.mil.
Sarah L NorrisU.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), 1425 Porter Street, Fort Detrick, Frederick, MD 21702-5011, United States.
Elizabeth S BrownClinicalRM, USAMRIID, 1425 Porter Street, Fort Detrick, Frederick, MD 21702-5011, United States.
Manmohan V RanadiveGoldbelt Raven LLC, USAMRIID, 1425 Porter Street, Fort Detrick, Frederick, MD 21702-5011, United States.
Barbara A SchiblyGoldbelt Raven LLC, USAMRIID, 1425 Porter Street, Fort Detrick, Frederick, MD 21702-5011, United States.
George E BettingerUniversity of Texas Medical Branch, Galveston, TX 77555, United States.
Nandadeva LokugamageUniversity of Texas Medical Branch, Galveston, TX 77555, United States.
Lawrence KormanU.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), 1425 Porter Street, Fort Detrick, Frederick, MD 21702-5011, United States.
John C MorrillUniversity of Texas Medical Branch, Galveston, TX 77555, United States.
Clarence J PetersUniversity of Texas Medical Branch, Galveston, TX 77555, United States.
United States Army Medical Research Institute of Infectious Diseases · USThe University of Texas Medical Branch at Galveston · USClinical Research Management · US

Funding

Rift Valley Fever Virus MP-12 Vaccine CompletionUC1AI062636 · NIAID · UNIVERSITY OF TEXAS MEDICAL BR GALVESTON · PI PETERS, CLARENCE J. · 2004 to 2004
$5.7M
NIAID NIH HHS 1UC1AI-062636-01NIAID NIH HHS UC1 AI062636
6 · The paper itself

Abstract

An outbreak or deliberate release of Rift Valley fever (RVF) virus could have serious public health and socioeconomic consequences. A safe RVF vaccine capable of eliciting long-lasting immunity after a single injection is urgently needed. The live attenuated RVF MP-12 vaccine candidate has shown promise in Phase 1 clinical trials; no evidence of reversion to virulence has been identified in numerous animal studies. The objective of this Phase 2 clinical trial was to (a) further examine the safety and immunogenicity of RVF MP-12 in RVF virus-naïve humans and (b) characterize isolates of RVF MP-12 virus recovered from the blood of vaccinated subjects to evaluate the genetic stability of MP-12 attenuation. We found that RVF MP-12 was well tolerated, causing mostly mild reactions that resolved without sequelae. Of 19 subjects, 18 (95%) and 19 (100%) achieved, respectively, 80% and 50% plaque reduction neutralization titers (PRNT80 and PRNT50)≥1:20 by postvaccination day 28. All 18 PRNT80 responders maintained PRNT80 and PRNT50≥1:40 until at least postvaccination month 12. Viremia was undetectable in the plasma of any subject by direct plaque assay techniques. However, 5 of 19 vaccinees were positive for MP-12 isolates in plasma by blind passage of plasma on Vero cells. Vaccine virus was also recovered from buffy coat material from one of those vaccinees and from one additional vaccinee. Through RNA sequencing of MP-12 isolates, we found no reversions of amino acids to those of the parent virulent virus (strain ZH548). Five years after a single dose of RVF MP-12 vaccine, 8 of 9 vaccinees (89%) maintained a PRNT80≥1:20. These findings support the continued development of RVF MP-12 as a countermeasure against RVF virus in humans.

Indexed as

AdultAnimalsAntibodies, ViralChlorocebus aethiopsFemaleGenomic InstabilityHumansMaleMiceMiddle AgedNeutralization TestsRift Valley FeverRift Valley fever virusVaccines, AttenuatedVero CellsViral VaccinesAntibodies, ViralVaccines, AttenuatedViral VaccinesClinical trialMP-12Rift Valley feverVaccine

Identifiers

PMID26706271
PMCPMC4731098
OpenAlexW2200196815

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.