HIV Infections
Conditions
Keywords
AIDS
Brief summary
This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.
Interventions
BIOLOGICALMRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
BIOLOGICALMRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
BIOLOGICALMRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Demonstrates good general health * Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis C (HCV) seronegative * Low risk of acquiring HIV infection * ALT lab value within normal range
Exclusion criteria
* Previously received an investigational HIV vaccine * Has a known or suspected impairment of immunologic function * Has a clinically significant chronic medical condition that is considered progressive * Has a major psychiatric illness * Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer * Weighs less than 105 lbs. * Has a recent (within two years) history of chronic alcohol abuse * Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia * Female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study * Male subject is planning to impregnate or provide sperm donation during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks | 30 weeks |
Participant flow
Recruitment details
Phase IIa; First Patient In: 24-Oct-2006; Last Patient Last Visit 30-May-2008. 21 sites, all in the United States of America.
Pre-assignment details
All patients had to demonstrate good health, be at low risk of acquiring HIV infection, and met a number of laboratory criteria. They could not have previously received an investigational HIV vaccine, had a contraindication to intramuscular injection, or weighed less than 105 pounds.
Participants by arm
| Arm | Count |
|---|---|
| MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. | 71 |
| MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. | 71 |
| MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. | 68 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 3 | 4 |
| Overall Study | patient traveling outside the country | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose | MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose | MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose | Total |
|---|---|---|---|---|
| Age, Continuous | 30.6 years | 31.5 years | 32.0 years | 31.4 years |
| Ethnicity Hispanic or Latino | 9 Participants | 9 Participants | 12 Participants | 30 Participants |
| Ethnicity Not Hispanic or Latino | 62 Participants | 62 Participants | 56 Participants | 180 Participants |
| Race Asian | 1 participants | 2 participants | 4 participants | 7 participants |
| Race Black or African American | 9 participants | 9 participants | 10 participants | 28 participants |
| Race Multi-Racial | 4 participants | 3 participants | 1 participants | 8 participants |
| Race Other (Unknown) | 0 participants | 0 participants | 1 participants | 1 participants |
| Race White | 57 participants | 57 participants | 52 participants | 166 participants |
| Sex: Female, Male Female | 31 Participants | 38 Participants | 37 Participants | 106 Participants |
| Sex: Female, Male Male | 40 Participants | 33 Participants | 31 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 56 / 71 | 63 / 71 | 60 / 68 |
| serious Total, serious adverse events | 0 / 71 | 0 / 71 | 2 / 68 |
Outcome results
Primary
Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks
Time frame: 30 weeks
Population: No data analysis was performed.