None listed
Conditions
Interventions
Group 1 Type of group
They will receive three doses of 1.0 mL of the gag / pol / nef HIV-1 vaccine in Merck serotype 5 adenovirus (MRKAd5)
Group name:Group 3 Type of group
Placebo will be administered in one dose
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: a) The participant is between 18 and 45 years of age. b) The participant has signed the informed consent and the HIPAA authorization form c) The participant performs following laboratory tests with results in the specified ranges within 45 days of the randomization: Negative serological tests for VlH-1 and ALT <3x ULN d) The participant is at high risk of contracting HIV infection e) The potentially fertile participant agrees to use an acceptable method of contraception until Week 30 of the study
Exclusion criteria
Exclusion criteria: a) Participants who have been in a monogamous relationship with a HIV-1 seronegative partner for> 1 year. b) Participants with a history of anaphylaxis and / or allergy to the components of the vaccine. c) Participants who have been administered immune globulin or blood products 3 months before. d) Participants who have been vaccinated with a live virus vaccine within the previous 30 days. e) Participants who have been vaccinated with an inactive vaccine within 5 days prior to injection with the first dose of the vaccine or scheduled within 14 days after the injection. f) Participants with a known history of immunodeficiency. g) Participants with a history of malignancy. h) Participants with a contraindication to receive intramuscular injections. j) Participants who have received an experimental HIV vaccine before. k) Participants who abuse or are actively dependent on drugs or alcohol. l) Participants who have a condition that can endanger the health of the participant or interfere with the evaluation of the objectives of the study. m) Participants who have not demonstrated that they understand informed consent and their review of study procedures and the risks of participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of: 1) ALT 2) T cells, hemoglobin, platelets, absolute neutrophil count 3) Clinical evaluation Measure:Safety of gag / pol / nef HIV-1 vaccine, MRKAd5 Timepoints:1) ALT: Day 1 2) 2) T cells, hemoglobin, platelets, absolute neutrophil count, day 1, week 3. 3) CLINICAL EVALUATION: Weeks 1, 2 3, 8, 12, 26, 39, 52, 78, 104, 130, 156, 182, 208, 210 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Status of HIV-1 infection: Detection of antibodies against HIV-1 Viral load: log10 of the viral load measured by PCR Measure:Efficacy of HIV-1 gag / pol / nef vaccine, MRKAd5: Status of HIV-1 infection (infected or uninfected). Reference value of viral load (HIV-1 RNA within 3 months after diagnosis). Timepoints:Detection of antibodies against HIV-1: Weeks 12, 30, 52, 78, 104, 130, 156, 182 and 208. HIV 1 RNA: Weeks 8 and 12 ; Outcome name:Serum for neutralizing Ab test for Ad5. Serological tests for concomitant infections. Multiplexed test for gag / pol / nef HIV-1 antibodies. PBMC for Merck. PBMC for HVTN. HLA typing. Genotyping of susceptibility to HIV-l. Measure:Immunogenicity of gag / pol / nef HIV-1 vaccine, MRKAd5 Timepoints:Serum for neutralizing Ab test for Ad5: Day 1 Serological tests for concomitant infections: Day 1 Multiplexed test for gag / pol / nef HIV-1 antibodies: Weeks 8, 30, 52, 104. PBMC for Merck: Weeks 8, 30, 104. PBMC for HVTN: Weeks 30, 52. HLA typing: Week 8. Genotyping of susceptibility to HIV-l: Week 8. | — |
Countries
Australia, Brazil, Canada, Dominican Republic, Haiti, Jamaica, Puerto Rico, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed