NCT00894114

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2003

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

6.1 years

First QC Date

May 4, 2009

Last Update Submit

May 27, 2015

Conditions

HIV-1 Infection

Outcome Measures

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.

    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

    4 weeks following vaccination

Study Arms (4)

Stratum 1

OTHER

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

Biological: Comparator: ALVAC-HIV vaccine

Stratum 2

EXPERIMENTAL

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

Biological: V520Biological: Comparator: ALVAC-HIV vaccine

Stratum 3

EXPERIMENTAL

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: V520Biological: Comparator: ALVAC-HIV vaccine

Stratum 4

EXPERIMENTAL

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: V520Biological: Comparator: ALVAC-HIV vaccine

Interventions

V520BIOLOGICAL

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

Stratum 2Stratum 3Stratum 4
Comparator: ALVAC-HIV vaccineBIOLOGICAL

A single dose 0.1 intramuscular injection

Stratum 1Stratum 2Stratum 3Stratum 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 6, 2009

Study Start

May 1, 2003

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 28, 2015

Record last verified: 2015-05