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CompletedNCT00894114Updated May 28, 2015

A Study of Safety, Tolerability and Immunogenicity of a 1-Dose Regimen of MRKAd5 HIV-1 Gag Vaccine Versus the ALVAC_HIV Vaccine (V520-019)

A Phase 1 interventional study of V520 and Comparator: ALVAC-HIV vaccine in HIV-1 Infection, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-28.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to determine whether patients previously primed with Ad5 of MRKAd5 HIV-1 gag vaccine respond better when boosted with ALVAC-HIV vaccine than when boosted with MKRAd5 HIV-1 gag vaccine.

02

Conditions studied

  • HIV-1 Infection
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject was previously enrolled in Merck HIV Vaccine study V520 Protocol 007 or 012, and received the complete 3-dose regimen during participation
  • Subject is in good general health
  • Subject is not infected with HIV
  • Subject agrees not to donate blood during the first 52 weeks of the study
  • Subject agrees not to donate sperm during the first 12 weeks of the study
  • Subject who is of reproductive potential agrees to use an acceptable method of birth control through Week 12 of the study

Exclusion criteria

Exclusion Criteria:

  • Subject has been administered immune globulin or blood product 3 months prior to receiving study vaccination
  • Subject has been vaccinated with a live virus vaccine in the past 30 days
  • Subject has been vaccinated with an inactivated vaccine in the past 14 days
  • Subject has an active medical disease
  • Subject is taking daily required prescription drugs
  • Female subject is pregnant, breastfeeding or expecting to conceive
  • Subject is positive for HIV
  • Subject has used injection drug within the past year
  • Subject has a sexual partner that is infected with HIV
  • Subject has a sexual partner that is an active injection drug user
  • Subject has been treated for or diagnosed with a new sexually transmitted disease in the past 6 months
  • Subject engaged in unprotected intercourse with more than 2 persons in the previous 6 months
  • Subject engaged in protected intercourse with more than 4 persons in the previous 6 months
  • Subject has previously participated in an HIV vaccine clinical trial (other than Merck V520 Protocols 007 and 012)
  • Subject weighs less than 110 lbs.
  • Subject has a recent history of alcohol abuse
  • Subject intends to donate blood in the first 52 weeks of the trial
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
250 participants (actual)

Study arms

  • Other
    Stratum 1

    Placebo recipients in the parent protocol (Merck V520 Protocols 007 or 012) will receive ALVAC-HIV Vaccine

    Biological: Comparator: ALVAC-HIV vaccine

  • Experimental
    Stratum 2

    Nonresponders who received active vaccine in parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine

    Biological: V520 · Biological: Comparator: ALVAC-HIV vaccine

  • Experimental
    Stratum 3

    Low responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine

    Biological: V520 · Biological: Comparator: ALVAC-HIV vaccine

  • Experimental
    Stratum 4

    High responders who received active vaccine in the parent protocol will be randomized to receive ALVAC-HIV vaccine or MRKAd5 HIV-1 gag vaccine

    Biological: V520 · Biological: Comparator: ALVAC-HIV vaccine

Interventions

  • BiologicalV520

    MRKAd5 HIV-1 gag vaccine, a single dose 1.0 mL intramuscular injection

  • BiologicalComparator: ALVAC-HIV vaccine

    A single dose 0.1 intramuscular injection

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of ALVAC-HIV or MRKAd5 HIV-1 vaccine in subjects who previously received a 3-dose regimen of Ad5 HIV-1 gag vaccine measured by number of injection-site adverse experiences (AE), non serious systemic AE, lab AE, serious AE.

    Time frame: Injection-site AE up to 5 days after vaccination, non-serious systemic AE and Lab AE up to 29 days after vaccination, serious AE for the entire study period (Week 260).

Secondary outcomes

  1. immunogenicity of a single-dose regimen of the ALVAC-HIV vaccine or MRKAd5 HIV-1 vaccine measured by various assays

    Time frame: 4 weeks following vaccination

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00894114
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
May 6, 2009
Start date
May 2003
Primary completion
Jun 2009
Completion
Jun 2009
Last update
May 28, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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