NCT01260727

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_1 hiv-infections

Geographic Reach
4 countries

4 active sites

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

February 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

3.8 years

First QC Date

December 14, 2010

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

HIV Preventive Vaccine

Outcome Measures

Primary Outcomes (2)

  • Severe local toxicity at injection site

    Measured after each vaccination

  • Severe systemic symptoms judged to be probably or definitely related to the vaccine

    Measured after each vaccination

Study Arms (6)

Group 1

EXPERIMENTAL

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.

Biological: PENNVAX-G DNA VaccineBiological: MVA-CMDR Vaccine

Group 2

EXPERIMENTAL

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.

Biological: PENNVAX-G DNA VaccineBiological: MVA-CMDR Vaccine

Group 3: Subgroup 1

EXPERIMENTAL

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.

Biological: PENNVAX-G DNA VaccineBiological: MVA-CMDR Vaccine

Group 3: Subgroup 2

PLACEBO COMPARATOR

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.

Biological: Placebo PENNVAX-G VaccineBiological: Placebo MVA-CMDR Vaccine

Group 4: Subgroup 1

EXPERIMENTAL

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.

Biological: PENNVAX-G DNA VaccineBiological: MVA-CMDR Vaccine

Group 4: Subgroup 2

PLACEBO COMPARATOR

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.

Biological: Placebo PENNVAX-G VaccineBiological: Placebo MVA-CMDR Vaccine

Interventions

PENNVAX-G DNA VaccineBIOLOGICAL

PENNVAX-G DNA (HIV-1 env A, C, and D, and consensus gag plasmids) vaccine; 4 mg administered IM as a total volume of 1 mL

Group 1Group 2Group 3: Subgroup 1Group 4: Subgroup 1
MVA-CMDR VaccineBIOLOGICAL

MVA-CMDR live attenuated modified vaccinia ankara vector (HIV-1 CM235 env/CM240 gag/pol); 1 x 10\^8 plaque-forming unit (pfu) administered IM by needle and syringe as a volume of 1 mL in either deltoid

Group 1Group 2Group 3: Subgroup 1Group 4: Subgroup 1
Placebo PENNVAX-G VaccineBIOLOGICAL

Sodium Chloride Injection USP, 0.9%

Group 3: Subgroup 2Group 4: Subgroup 2
Placebo MVA-CMDR VaccineBIOLOGICAL

Sodium Chloride Injection USP, 0.9%

Group 3: Subgroup 2Group 4: Subgroup 2

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Low risk of HIV infection (as defined by the Study Risk Assessment Tool captured during the medical history)
  • Amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit, and committed to 18 months of follow-up contact
  • Pass the Test of Understanding and demonstrate an understanding of STEP study results (HVTN 502/Merck 023 trial)
  • Assessed by the clinic staff as being at low risk of HIV infection on the basis of sexual behaviors within the 12 months prior to enrollment as follows: sexually abstinent, or had two or fewer mutually monogamous relationships with HIV-uninfected partners and who have not used illicit drugs, or had two or fewer partners believed to be HIV uninfected and who did not use illicit drugs and with whom he/she regularly uses condoms for sexual intercourse
  • Healthy men and women (determined by medical history, physical examination, and clinical judgment)
  • Available and willing to participate for 12 months for study visits and annual follow-up for 18 months after study completion
  • Must be willing to have photo or fingerprint taken for identification purposes
  • Must be willing to be taken home at enrollment visit and allow home visits, if needed
  • Able to read and willing to complete the informed consent process
  • Has the following laboratory criteria within 45 days prior to study entry:
  • Hemoglobin: Women: 11 mg/dL; Men: 12.5 mg/dL
  • White cell count: 2,500 to 11,000 cells/mm\^3
  • Platelets: 125,000 to 450,000 per mm\^3
  • Urinalysis: protein and blood less than 1+, glucose negative
  • Normal liver function tests to include alanine aminotransferase (ALT)/aspartate aminotransferase (AST), alkaline phosphatase, gamma-glutamyl transpeptidase (GGT) (less than or equal to 1.25 times the institutional upper limits of normal), creatine phosphokinase (CPK) (less than or equal to 600 IU/L), troponin I (less than 0.4 ng/mL), and creatinine (less than or equal to 1.25 times the institutional upper limits of normal)
  • +4 more criteria

You may not qualify if:

  • Confirmed HIV-1 or HIV-2 infection
  • Engaged in excessive daily alcohol use, frequent binge drinking, or illicit drug use within the 12 months prior to study entry
  • History of new onset, sexually acquired infection, as determined by local, syndromic diagnostics standards or, as available, serologic and microbiologic diagnosis within the 12 months prior to study entry
  • Has a known current high-risk partner or had such a partner within the 12 months prior to study entry
  • Hepatitis B, hepatitis C, or syphilis infection; active syphilis documented by exam or serology unless positive serology is because of remote treated infection or positive rapid plasma reagin
  • Pregnant, planning on becoming pregnant during the study, or breastfeeding
  • Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude study participation (e.g., history of seizure disorders, bleeding/clotting disorder, autoimmune disease, malignancy, tuberculosis, other systemic infections)
  • Major surgery within the 4 weeks prior to study entry
  • History of or known active heart disease including:
  • Previous myocardial infarction (heart attack)
  • Angina pectoris; congestive heart failure
  • Valvular heart disease, including mitral valve prolapse
  • Cardiomyopathy
  • Myo/pericarditis
  • Stroke or transient ischemic attack
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rockville Vaccine Assessment Clinic (RVAC)

Rockville, Maryland, 20850, United States

Location

Kenya Med. Research Inst./Walter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho

Kericho, 20200, Kenya

Location

National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) CRS

Mbeya, Tanzania

Location

Makerere University Walter Reed Project (MUWRP)

Kampala, Uganda

Location

Related Publications (3)

  • Cristillo AD, Weiss D, Hudacik L, Restrepo S, Galmin L, Suschak J, Draghia-Akli R, Markham P, Pal R. Persistent antibody and T cell responses induced by HIV-1 DNA vaccine delivered by electroporation. Biochem Biophys Res Commun. 2008 Feb 1;366(1):29-35. doi: 10.1016/j.bbrc.2007.11.052. Epub 2007 Nov 26.

    PMID: 18036339BACKGROUND

  • Loutfy MR, Harris M, Raboud JM, Antoniou T, Kovacs C, Shen S, Dufresne S, Smaill F, Rouleau D, Rachlis A, Gough K, Lalonde R, Tsoukas C, Trottier B, Walmsley SL, Montaner JS. A large prospective study assessing injection site reactions, quality of life and preference in patients using the Biojector vs standard needles for enfuvirtide administration. HIV Med. 2007 Oct;8(7):427-32. doi: 10.1111/j.1468-1293.2007.00489.x.

    PMID: 17760734BACKGROUND

  • Ake JA, Schuetz A, Pegu P, Wieczorek L, Eller MA, Kibuuka H, Sawe F, Maboko L, Polonis V, Karasavva N, Weiner D, Sekiziyivu A, Kosgei J, Missanga M, Kroidl A, Mann P, Ratto-Kim S, Anne Eller L, Earl P, Moss B, Dorsey-Spitz J, Milazzo M, Laissa Ouedraogo G, Rizvi F, Yan J, Khan AS, Peel S, Sardesai NY, Michael NL, Ngauy V, Marovich M, Robb ML. Safety and Immunogenicity of PENNVAX-G DNA Prime Administered by Biojector 2000 or CELLECTRA Electroporation Device With Modified Vaccinia Ankara-CMDR Boost. J Infect Dis. 2017 Nov 27;216(9):1080-1090. doi: 10.1093/infdis/jix456.

    PMID: 28968759DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • MAJ Julie Ake, MD

    U.S. Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR)

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 15, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2013

Study Completion

June 1, 2015

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

UG(1)US(1)KE(1)TA(1)