A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00849680

First received: February 20, 2009

Last updated: June 9, 2011

Last verified: June 2011

History of Changes

Results First Received: June 9, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Conditions:	HIV-1 HIV Infections
Interventions:	Other: Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine Biological: Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) Biological: Comparator: Placebo to MRKAd5 HIV-1 gag vaccine

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
317 participants were randomized. 2 did not receive any study medication. Therefore, the safety population was 315.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo	2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)	3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)	3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)	3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)	3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)	3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)	2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)	3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.

Participant Flow: Overall Study

	Placebo	Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)
STARTED	27	13	42	42	42	42	78	31
COMPLETED	16	10	27	28	32	27	61	23
NOT COMPLETED	11	3	15	14	10	15	17	8
Adverse Event	0	0	0	0	0	0	2	0
Lost to Follow-up	7	3	12	11	8	11	12	5
Subject moved	1	0	3	1	0	2	2	2
Withdrawal by Subject	2	0	0	2	2	2	1	1
Subject unable to comply with protocol	1	0	0	0	0	0	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Placebo	2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)	3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)	3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)	3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)	3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)	3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)	2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)	3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)	Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)	Total
Number of Participants [units: participants]	27	13	42	42	42	42	78	31	317
Age, Customized [units: Years] Mean ( Full Range )	32.4 ( 19 to 50 )	34.3 ( 18 to 46 )	33.2 ( 19 to 50 )	32.6 ( 19 to 50 )	33.3 ( 18 to 50 )	34.0 ( 18 to 50 )	35.7 ( 19 to 50 )	34.8 ( 19 to 50 )	34.0 ( 18 to 50 )
Gender [units: participants]
Female	19	12	21	14	17	21	31	14	149
Male	8	1	21	28	25	21	47	17	168
Region of Enrollment [units: participants]
United States	27	13	42	42	42	42	78	31	317

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants With Adverse Experiences [ Time Frame: up to 260 weeks after first vaccination ]

Show Outcome Measure 1

2. Primary:

Number of Participants With Laboratory Adverse Experiences [ Time Frame: up to 260 weeks after first vaccination ]

Show Outcome Measure 2

3. Primary:

Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 3-dose Vaccine Regimen [ Time Frame: 4 weeks after booster injection ]

Show Outcome Measure 3

4. Primary:

Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 2-dose Vaccine Regimen [ Time Frame: 4 weeks after booster injection ]

Show Outcome Measure 4

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

As this study is part of a multicenter trial, publications derived from this study should include input from the principal investigator, his/her colleagues, the other investigators in this trial, and SPONSOR personnel.

The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. SPONSOR review can be expedited to meet publication guidelines.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
An interim analysis of a related study, V520 Protocol 023 (NCT00095576), showed that the MRKAd5 vaccine used in Protocol 016 (NCT00849680) was not efficacious; therefore, only a high level summary of the safety data was performed.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck, Sharp & Dohme
e-mail: clinicaltrialsdisclosure@merck.com

Publications:

Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM, Brown SJ, Kulkarni P, Dubey SA, Kierstead LS, Casimiro DR, Mogg R, DiNubile MJ, Shiver JW, Leavitt RY, Robertson MN, Mehrotra DV, Quirk E; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008 Jun 1;46(11):1769-81.

Publications automatically indexed to this study:

Li F, Finnefrock AC, Dubey SA, Korber BT, Szinger J, Cole S, McElrath MJ, Shiver JW, Casimiro DR, Corey L, Self SG. Mapping HIV-1 vaccine induced T-cell responses: bias towards less-conserved regions and potential impact on vaccine efficacy in the step study. PLoS One. 2011;6(6):e20479. Epub 2011 Jun 10.

Hutnick NA, Carnathan DG, Dubey SA, Cox KS, Kierstead L, Makadonas G, Ratcliffe SJ, Lasaro MO, Robertson MN, Casimiro DR, Ertl HC, Betts MR. Vaccination with Ad5 vectors expands Ad5-specific CD8 T cells without altering memory phenotype or functionality. PLoS One. 2010 Dec 22;5(12):e14385.

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme
ClinicalTrials.gov Identifier:	NCT00849680 History of Changes
Other Study ID Numbers:	V520-016, 2009_548
Study First Received:	February 20, 2009
Results First Received:	June 9, 2011
Last Updated:	June 9, 2011
Health Authority:	United States: Food and Drug Administration

To Top