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RV 262

Status
Completed
Phase
I
Principal Investigator(s)
MAJ Julie Ake, MD
Objective

The purpose of this study is to evaluate the safety of and immune response to an HIV vaccine, administered using two different devices, followed by a vaccine boost, in healthy, HIV-uninfected adults.



last updated March 30, 2021
Prevention Option(s)
HIV Vaccine
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
Participants will receive PENNVAX-G vaccine administered by intramuscular injection (IM) via Biojector 2000 needleless device in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168.
Mode of Delivery
Intramuscular
Products
DNA
MVA
ARMs
Experimental
Clade
A
C
D
Description
Participants will receive PENNVAX-G vaccine administered via CELLECTRA EP in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168.
Mode of Delivery
Intramuscular
Products
DNA
MVA
ARMs
Experimental
Clade
A
C
D
Description
Participants will receive PENNVAX-G vaccine administered IM via Biojector 2000 needleless device in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168.
Mode of Delivery
Intramuscular
Products
DNA
MVA
ARMs
Experimental
Clade
A
C
D
Description
Participants will receive placebo vaccine for PENNVAX-G administered IM via Biojector 2000 needless device in either deltoid on Days 0 and 28. They will then receive placebo vaccine for MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Description
Participants will receive PENNVAX-G vaccine administered IM via CELLECTRA EP in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168.
Mode of Delivery
Intramuscular
Products
DNA
MVA
ARMs
Experimental
Clade
A
C
D
Description
Participants will receive placebo vaccine for PENNVAX-G administered IM via CELLECTRA EP in either deltoid on Days 0 and 28. They will then receive placebo vaccine for MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Results
Safety and Immunogenicity of PENNVAX-G DNA Prime Administered by Biojector 2000 or CELLECTRA Electroporation Device With Modified Vaccinia Ankara-CMDR Boost
Official Code
NCT01260727
Related Publications
A large prospective study assessing injection site reactions, quality of life and preference in patients using the Biojector vs standard needles for enfuvirtide administration
Persistent antibody and T cell responses induced by HIV-1 DNA vaccine delivered by electroporation
Similar Trials
RV 144
Trial Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
February 2010
June 2015
Date of Enrollment Completion
December 1, 2013
Enrollment
92
18
Years
49
Years
Population
Men
Women
Sites

Makerere University Walter Reed Project (MUWRP)

Kampala
Uganda

Mbeya Med. Research Program, Mbeya Referral Hospital CRS

Mbeya
United Republic of Tanzania

Rockville Vaccine Assessment Clinic (RVAC)

Rockville, Maryland
United States of America

USAMRU-K, Walter Reed Project, Kericho District Hospital CRS

Kericho
Kenya