A Phase 2 interventional study of Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose) and Comparator: placebo in AIDS and HIV Infections, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-06.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Prevention
This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.
On September 18, 2007 the Protocol V520-023 DSMB (Data \& Safety Monitoring Board) reviewed data from a planned interim analysis. These data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted.
Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective.
No further treatment was given in V520-023, however participants were followed. V520-023 protocol ended earlier than originally planned per protocol and participants (HIV infected and uninfected) had the option of participating in an observational long term follow up protocol called V520-030/HVTN 504, which served as an extension of V520-023 and would continue through the end of 2009.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 3,000 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10\^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
Drug: Comparator: placebo
Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10\^10 adenovirus genomes \[ad-vg\]/dose). This dose is equivalent to 3x10\^10 vp/dose used in study V520-016.
Also known as: V520
Placebo to Trivalent MRKAd5 HIV-1 gag/pol/nef in three 1 mL doses at Day 1, Week 4, and Week 26 administered intramuscularly.
Number of Participants With Clinical Adverse Experiences
Number of participants with non-serious AEs with an incidence cut-off of 5% (\>5% in at least one treatment group) and number of participants with \>1 SAE following administration of study vaccine. AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210). Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose.
Time frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)
Number of Participants With Laboratory Adverse Experiences
Number of participants with laboratory adverse experiences with an incidence cut-off of 5% (events occurring \> 5% in at least one treatment group) following administration of the first dose of study vaccine. Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body. All laboratory AEs were collected up to 14 days after any vaccine dose.
Time frame: Day 1 to Week 208
Number of Participants With HIV-1 Infections
The number of participants with HIV-1 infections was to be determined with a periodic HIV-1 screening test to detect antibodies to recombinant HIV-1 envelope protein in the participants' serum.
Time frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)
HIV-1 Viral Load in Infected Participants
Plasma HIV-1 viral RNA was to be measured using a ribonucleic acid polymerase chain reaction (RNA PCR) on the last archived sample, and at Weeks 1, 2, 8, 12, and 26 post-HIV-1 infection, and subsequently every 6 months.
Time frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)
3000 participants were enrolled and randomized in the study. However, only 2979 received study vaccination, and are included in the started population. V520-023 was terminated early based on findings at a planned interim analysis and subjects were encouraged to participate in the V520-030 rollover study for additional long term follow up.
| Milestone | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | Placebo |
|---|---|---|
| Started | 1484 | 1495 |
| Vaccinated at visit 2 (dose 1) | 1484 | 1495 |
| Vaccinated at visit 4 (dose 2) | 1426 | 1443 |
| Vaccinated at visit 7 (dose 3) | 1328 | 1361 |
| Completed | 9 | 14 |
| Not completed | 1475 | 1481 |
| Withdrew: Adverse event | 5 | 3 |
| Withdrew: Lost to follow-up | 233 | 229 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 34 | 47 |
| Withdrew: Option to switch to a rollover study | 1097 | 1099 |
| Withdrew: Site terminated | 75 | 67 |
| Withdrew: Subject moved | 30 | 36 |
Number of participants with non-serious AEs with an incidence cut-off of 5% (\>5% in at least one treatment group) and number of participants with \>1 SAE following administration of study vaccine. AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210). Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose.
| Participants | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | Placebo |
|---|---|---|
| With non-serious adverse events (NSAE) | 1221 | 946 |
| With no non-serious adverse events | 263 | 549 |
| With serious adverse events | 19 | 17 |
| With no serious adverse events | 1465 | 1478 |
Number of participants with laboratory adverse experiences with an incidence cut-off of 5% (events occurring \> 5% in at least one treatment group) following administration of the first dose of study vaccine. Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body. All laboratory AEs were collected up to 14 days after any vaccine dose.
| Participants | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | Placebo |
|---|---|---|
| Number of Participants With Laboratory Adverse Experiences | 0 | 0 |
The number of participants with HIV-1 infections was to be determined with a periodic HIV-1 screening test to detect antibodies to recombinant HIV-1 envelope protein in the participants' serum.
No measurements were reported for this outcome.
Plasma HIV-1 viral RNA was to be measured using a ribonucleic acid polymerase chain reaction (RNA PCR) on the last archived sample, and at Weeks 1, 2, 8, 12, and 26 post-HIV-1 infection, and subsequently every 6 months.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | — | 19/1,484 (1.3%) | 1,221/1,484 (82.3%) |
| Placebo | — | 17/1,495 (1.1%) | 946/1,495 (63.3%) |
| Event | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | Placebo |
|---|---|---|
| Congenital cardiovascular anomalyCongenital, familial and genetic disorders | 0/1484 | 2/1495 |
| Anemia aggravatedBlood and lymphatic system disorders | 1/1484 | 0/1495 |
| FeverGeneral disorders | 1/1484 | 0/1495 |
| RigorsGeneral disorders | 1/1484 | 0/1495 |
| Cholecystitis acuteHepatobiliary disorders | 1/1484 | 0/1495 |
| Gastroenteritis viralInfections and infestations | 1/1484 | 0/1495 |
| Shunt infectionInfections and infestations | 1/1484 | 0/1495 |
| Staphylococcal abscessInfections and infestations | 1/1484 | 0/1495 |
| Vulval abscessInfections and infestations | 1/1484 | 0/1495 |
| Gun shot woundInjury, poisoning and procedural complications | 1/1484 | 1/1495 |
| Event | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | Placebo |
|---|---|---|
| Injection site painGeneral disorders | 961/1484 | 475/1495 |
| HeadacheNervous system disorders | 461/1484 | 394/1495 |
| FeverGeneral disorders | 376/1484 | 309/1495 |
| Injection site swellingGeneral disorders | 337/1484 | 115/1495 |
| Injection site erythemaGeneral disorders | 317/1484 | 143/1495 |
| Injection site tendernessGeneral disorders | 271/1484 | 81/1495 |
| FatigueGeneral disorders | 170/1484 | 120/1495 |
| DiarrhoeaGastrointestinal disorders | 156/1484 | 148/1495 |
| NauseaGastrointestinal disorders | 94/1484 | 75/1495 |
| Sore throatRespiratory, thoracic and mediastinal disorders | 83/1484 | 83/1495 |
| Age, Continuous(years) | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | Placebo | Total |
|---|---|---|---|
| Mean | 29.9 ± 7.8 | 30.2 ± 8.13 | 30.1 ± 7.97 |
| Sex: Female, Male(Participants) | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef | Placebo | Total |
|---|---|---|---|
| Female | 565 | 570 | 1135 |
| Male | 919 | 925 | 1844 |
No study locations are listed for this record.
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Merck Sharp & Dohme LLC