Evidence map›Paper›PMID 23418465›Full record

Trial reportPloS one2013

Safety and immunogenicity of DNA and MVA HIV-1 subtype C vaccine prime-boost regimens: a phase I randomised Trial in HIV-uninfected Indian volunteers.

Sanjay Mehendale, Madhuri Thakar, Seema Sahay, Makesh Kumar, Ashwini Shete, Pattabiraman Sathyamurthi, Amita Verma, Swarali Kurle, Aparna Shrotri, Jill Gilmour and 11 more

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.4field-weighted citation impact, top 7% 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

24 citing papers in PubMed, 46 citations in OpenAlex.

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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

21 authors at 6 institutions in 3 countries.

Sanjay MehendaleNational Institute of Epidemiology, Chennai, India. sanjaymehendale@icmr.org.in
Madhuri Thakar
Seema Sahay
Makesh Kumar
Ashwini Shete
Pattabiraman Sathyamurthi
Amita Verma
Swarali Kurle
Aparna Shrotri
Jill Gilmour
Rajat Goyal
Len Dally
Eddy Sayeed
Devika Zachariah
James Ackland
Sonali Kochhar
Josephine H Cox
Jean-Louis Excler
Vasanthapuram Kumaraswami
Ramesh Paranjape
Vadakkuppatu Devasenapathi Ramanathan
National AIDS Research Institute · INInternational AIDS Vaccine Initiative · USNational Institute of Research in Tuberculosis · INEmmes (United States) · USImperial College London · GBNational Institute of Epidemiology · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designA randomized, double-blind, placebo controlled phase I trial.

methodsThe trial was conducted in 32 HIV-uninfected healthy volunteers to assess the safety and immunogenicity of prime-boost vaccination regimens with either 2 doses of ADVAX, a DNA vaccine containing Chinese HIV-1 subtype C env gp160, gag, pol and nef/tat genes, as a prime and 2 doses of TBC-M4, a recombinant MVA encoding Indian HIV-1 subtype C env gp160, gag, RT, rev, tat, and nef genes, as a boost in Group A or 3 doses of TBC-M4 alone in Group B participants. Out of 16 participants in each group, 12 received vaccine candidates and 4 received placebos.

resultsBoth vaccine regimens were found to be generally safe and well tolerated. The breadth of anti-HIV binding antibodies and the titres of anti-HIV neutralizing antibodies were significantly higher (p<0.05) in Group B volunteers at 14 days post last vaccination. Neutralizing antibodies were detected mainly against Tier-1 subtype B and C viruses. HIV-specific IFN-γ ELISPOT responses were directed mostly to Env and Gag proteins. Although the IFN-γ ELISPOT responses were infrequent after ADVAX vaccinations, the response rate was significantly higher in group A after 1(st) and 2(nd) MVA doses as compared to the responses in group B volunteers. However, the priming effect was short lasting leading to no difference in the frequency, breadth and magnitude of IFN-γELISPOT responses between the groups at 3, 6 and 9 months post-last vaccination.

conclusionsAlthough DNA priming resulted in enhancement of immune responses after 1(st) MVA boosting, the overall DNA prime MVA boost was not found to be immunologically superior to homologous MVA boosting.

trial registrationClinical Trial Registry CTRI/2009/091/000051.

Indexed as

AdultAIDS VaccinesAntibodies, NeutralizingDouble-Blind MethodFollow-Up StudiesHIV-1HIV AntibodiesHIV InfectionsHumansIndiaTreatment OutcomeVaccines, DNAVacciniaVaccinia virusViral VaccinesAIDS VaccinesAntibodies, NeutralizingHIV AntibodiesMVA vaccineVaccines, DNAViral Vaccines

Identifiers

PMID23418465
PMCPMC3572184
OpenAlexW2008767788

What OpenQuestion holds

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LicenceCC BY
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.