FindTrial
Sign In

WORLD PHASE I STUDY OF CLIMBED DOSES ON THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF A 3-DOSE REGIME OF HIV-1 GAG VACCINE IN MRKAD5 IN HEALTHY ADULTS.

WORLD PHASE I STUDY OF CLIMBED DOSES ON THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF A 3-DOSE REGIME OF HIV-1 GAG VACCINE IN MRKAD5 IN HEALTHY ADULTS.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-033-03
Enrollment
30
Registered
2003-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

GAG del VIH-1 Type of group
Receive a regimen of 3 doses of 1.0 mL injections of either 1x10 ^ 9 or 1x10 ^ 10 viral particles / dose of the vaccine of GAG of HIV-1. Group name:Placebo Type of group
Receive a 3-dose regimen of 1.0 mL injections of placebo

Sponsors

Red Mundial de la Vacuna contra el Sida,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. The participant is between 18 and 50 (inclusive) years of age at the time of randomization. b. The participant has signed the informed consent and the format of HIPAA authorization (if applicable) before blood collection for selection. c. The participant demonstrates good general health assessed by a medical history, vital signs, physical examination and laboratory tests.

Exclusion criteria

Exclusion criteria: a. The participant has a history of anaphylaxis and / or allergy to the components of the vaccine, including Tris buffer, MgCli, and polysorbate 80. b. The participant has a recent history of febrile illness at the time of vaccination. c. The participant has received immunoglobulin or a blood product 3 months before the injection with the first dose of vaccine / placebo, or it is scheduled within 29 days thereafter. d. The participant has received a live virus vaccine within 30 days before receiving the first dose of vaccine / placebo or it is scheduled within 29 days thereafter. e. The participant has received an inactive vaccine within 14 days before receiving the first dose of vaccine / placebo, or this vaccine is scheduled within 29 days thereafter.

Design outcomes

Primary

MeasureTime frame
Outcome name:Urinalysis, LFT (including: ALT, alkaline phosphatase and total bilirubin) amylase, CBC / Dif., PT, PTT, C-reactive protein, CPK, Ca 2+, PO4, albumin and creatinine. Measure:Safety and tolerability of a 3-dose regimen of the HIV-I gag vaccine in MRKAdS with 1x10 ^ 9 and 1x10 ^ 10 viral particles / dose. Timepoints:Weeks 1, 2, 5, 6, 26, 27 and 28—

Secondary

MeasureTime frame
Outcome name:the ELISPOT data of the IFN-y specific for ungrouped gag will be summarized at each immunogenicity visit for Group 1 (placebo), for Group 2 (HIV-I gag vaccine in MRKAd5 with 1x10 ^ 9 vp / d), and Group 3 (HIV-1 gag vaccine in MRKAd5 with 1x10 ^ 10 vp / d). Measure:Summarize separately the immunogenicity of HIV-1 gag vaccine groups in MRKAd5 which is measured by ELISPOT assay of unfractionated JFN-y specific gag, intracellular cytokine staining assay and anti-gag assay -VIH at all other time points local and systemic reactions, temperature and laboratory values out of range observed in the regions participating in the study. Timepoints:Weeks 1, 2, 5, 6, 26, 27 and 28—

Countries

Peru, United States

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)