Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults

NCT00252148 | Completed Phase 1 DMC

• 1 other identifier: IAVI C002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the safety of an immune response to an investigational HIV vaccine, ADMVA, at three different dosage levels, in adults who are not infected with HIV

Conditions

HIV Infection

Keywords

HIV Preventive Vaccine

Outcome Measures

Primary Outcomes (1)

• safety and tolerability of AMVA

  18 months

Secondary Outcomes (1)

• Immunogenicity of ADMVA

  18 months

Study Arms (2)

ADMVA

ACTIVE COMPARATOR

ADMVA dosage escalation

Biological: ADMVA

Placebo

PLACEBO COMPARATOR

Placebo is 10mM TRIS HCl, 140mM NaCl, ph 7.7

Biological: ADMVA

Interventions

ADMVA BIOLOGICAL

experimental HIV vaccine, MVA vector expressing HIV clade C env, gag, pol, nef, and tat

ADMVA; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males and females, as assessed by a medical history, physical exam, and laboratory tests;
• Age of at least 18 years of age on the day of screening and no greater than 40 years on the day of first vaccination;
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 18 months);
• In the opinion of the principal investigator or designee has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed;
• Willing to undergo HIV Testing and counseling, and receive HIV test results;
• If sexually active female, using an effective method of contraception from screening until at least 4 months after last vaccination. All female volunteers must be willing to undergo urine pregnancy tests.
• If sexually active male, willing to use an effective method of contraception from screening until 4 months after the last vaccination and will be advised not to get his partner pregnant.

You may not qualify if:

• Confirmed HIV-1 or HIV-2 infection;
• Reported high-risk behavior for HIV infection defined as:
• Within 6 months before vaccination, the volunteer has:
• Had unprotected vaginal or anal sex with a known HIV infected person or with a casual partner.
• Engaged in sex work for money or drugs
• Used injection drugs (illicit), or
• Acquired an STD;
• Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the trial physician within the last 6 months;
• Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation;
• Any of the following abnormal laboratory parameters listed below:
• Hemoglobin: \<9.0 g/dL
• Absolute Neutrophil Count (ANL): ≤ 999/mm3
• Absolute Lymphocyte Count (ALC): ≤ 500/mm3
• Platelets: ≤ 90,000 ≥ 550,000/mm3
• Creatinine: \> 1.4 x ULN

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• Aaron Diamond AIDS Research Center: collaborator
• University of Rochester: collaborator

Study Sites (2)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (2)

• Vasan S, Schlesinger SJ, Chen Z, Hurley A, Lombardo A, Than S, Adesanya P, Bunce C, Boaz M, Boyle R, Sayeed E, Clark L, Dugin D, Boente-Carrera M, Schmidt C, Fang Q, LeiBa, Huang Y, Zaharatos GJ, Gardiner DF, Caskey M, Seamons L, Ho M, Dally L, Smith C, Cox J, Gill D, Gilmour J, Keefer MC, Fast P, Ho DD. Phase 1 safety and immunogenicity evaluation of ADMVA, a multigenic, modified vaccinia Ankara-HIV-1 B'/C candidate vaccine. PLoS One. 2010 Jan 25;5(1):e8816. doi: 10.1371/journal.pone.0008816.

  PMID: 20111599 RESULT

• Elizaga ML, Vasan S, Marovich MA, Sato AH, Lawrence DN, Chaitman BR, Frey SE, Keefer MC; MVA Cardiac Safety Working Group. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review. PLoS One. 2013;8(1):e54407. doi: 10.1371/journal.pone.0054407. Epub 2013 Jan 17.

  PMID: 23349878 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• David Ho, MD

  Aaron Diamond AIDS Research Center

  PRINCIPAL INVESTIGATOR

• Michael Keefer, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Soe Than, MD

  International AIDS Vaccine Initiative

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: January 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: February 11, 2013

Record last verified: 2010-06

Locations

US (2)