Evidence map›Paper›PMID 23221981›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2013

Feasibility and safety of ALVAC-HIV vCP1521 vaccine in HIV-exposed infants in Uganda: results from the first HIV vaccine trial in infants in Africa.

Kenneth Kintu, Philip Andrew, Philippa Musoke, Paul Richardson, Brenda Asiimwe-Kateera, Teopista Nakyanzi, Lei Wang, Mary Glenn Fowler, Lynda Emel, San-San Ou and 5 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

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  18. Nonreplicating vectors in HIV vaccines.Current opinion in HIV and AIDS · 2013
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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

15 authors at 8 institutions in 3 countries.

Kenneth KintuMakerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda. kkintu@mujhu.org
Philip Andrew
Philippa Musoke
Paul Richardson
Brenda Asiimwe-Kateera
Teopista Nakyanzi
Lei Wang
Mary Glenn Fowler
Lynda Emel
San-San Ou
Lynn Baglyos
Sanjay Gurunathan
Sheryl Zwerski
Jay Brooks Jackson
Laura Guay
Cancer Research Center · USJohns Hopkins University · USMUJHU Research Collaboration · UGSanofi (Mexico) · MXGeorge Washington University · USMakerere University · UGNational Institute of Allergy and Infectious Diseases · USTriangle · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
HIV PREVENTION TRIALS NETWORK LEADERSHIP GROUPU01AI046749 · NIAID · FAMILY HEALTH INTERNATIONAL · PI CATES, WILLARD · 1999 to 2005
$73.5M
Makerere Univ.-Johns Hopkins Univ. HIV Clinical Trials Unit-Kampala, UgandaU01AI069530 · NIAID · JOHNS HOPKINS UNIVERSITY · PI FOWLER, MARY GLENN · 2007 to 2011
$25.8M
MU-JHU HPTU TRIAL SITE--UGANDAU01AI048054 · NIAID · JOHNS HOPKINS UNIVERSITY · PI GUAY, LAURA A · 2000 to 2006
$14.4M
NIAID NIH HHS U01 AI046749NIAID NIH HHS U01 AI048054NIAID NIH HHS U01 AI068632NIAID NIH HHS U01AI068632NIAID NIH HHS U01 AI069530NIAID NIH HHS U01AI46749NIAID NIH HHS U01 AI48054NIAID NIH HHS UM1 AI068632
6 · The paper itself

Abstract

backgroundThe development of a safe and effective vaccine against HIV type 1 for the prevention of mother-to-child transmission of HIV would significantly advance the goal of eliminating HIV infection in children. Safety and feasibility results from phase 1, randomized, double-blind, placebo-controlled trial of ALVAC-HIV vCP1521 in infants born to HIV type 1-infected women in Uganda are reported.

methodsHIV-exposed infants were enrolled at birth and randomized (4:1) to receive vaccine or saline placebo intramuscular injections at birth, 4, 8, and 12 weeks of age. Vaccine reactogenicity was assessed at vaccination and days 1 and 2 postvaccination. Infants were followed until 24 months of age. HIV infection status was determined by HIV DNA polymerase chain reaction.

resultsFrom October 2006 to May 2007, 60 infants (48 vaccine and 12 placebo) were enrolled with 98% retention at 24 months. One infant was withdrawn, but there were no missed visits or vaccinations among the 59 infants retained. Immune responses elicited by diphtheria, polio, hepatitis B, haemophilus influenzae type B, and measles vaccination were similar in the 2 arms. The vaccine was well tolerated with no severe or life-threatening reactogenicity events. Adverse events were equally distributed across both study arms. Four infants were diagnosed as HIV infected [3 at birth (2 vaccine and 1 placebo) and 1 in vaccine arm at 2 weeks of age].

conclusionThe ALVAC-HIV vCP1521 vaccination was feasible and safe in infants born to HIV-infected women in Uganda. The conduct of high-quality infant HIV vaccine trials is achievable in Africa.

Indexed as

AIDS VaccinesHIV Envelope Protein gp120AdolescentAdultBreast FeedingChild, PreschoolDouble-Blind MethodFemaleHIV-1HIV InfectionsHumansInfantInfant, NewbornInfectious Disease Transmission, VerticalMilk, HumanTreatment OutcomeAIDS VaccinesAIDSVAXHIV Envelope Protein gp120

Identifiers

PMID23221981
PMCPMC3625520
OpenAlexW2073354565

What OpenQuestion holds

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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.