A Phase I Study to Evaluate the Safety and Immunogenicity of Heterologous Boost Immunizations With MVA-CMDR

NCT01889719 | Completed Phase 1 DMC

• 1 other identifier: SSC-0803
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are safe and whether they will boost immune responses generated by immunizations with a dendritic cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy HIV-uninfected volunteers.

Conditions

HIV

Keywords

HIV Prevention

Outcome Measures

Primary Outcomes (1)

• safety and tolerability of MVA-CMDR vaccine

  safety and tolerability of two intramuscular injections of MVA-CMDR vaccine candidate in healthy HIV-uninfected volunteers

  16 weeks

Study Arms (2)

Vaccination with MVA-CMDR Group 1

EXPERIMENTAL

Six to 27 subjects who previously received vaccination with DEC-205, will receive vaccination with MVA-CMDR

Biological: MVA-CMDR

Vaccination with MVA-CMDR Group 2

ACTIVE COMPARATOR

Six to 27 subjects who previously did not receive vaccination with DEC-205, will receive vaccination with MVA-CMDR

Biological: MVA-CMDR

Interventions

MVA-CMDR BIOLOGICAL

injections of MVA-CMDR vaccine

Vaccination with MVA-CMDR Group 1; Vaccination with MVA-CMDR Group 2

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Healthy adult males and females, as assessed by a medical history, physical exam, ECG, and laboratory tests;
• Age of at least 18 years of age on the day of screening and no greater than 62 years at time of vaccination;
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 12 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);
• Amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit;
• Assessed by the clinic staff as being at "low risk" for HIV infection on the basis of sexual behaviors within the 12 months prior to enrollment defined as follows:
• Sexually abstinent OR
• Had two or fewer mutually monogamous relationships with partners believed to be HIV-uninfected and who did not use illicit drugs (illicit drug use or abuse that includes any injection drugs, methamphetamines (crystal meth), heroin, cocaine, including crack cocaine or chronic marijuana abuse) OR
• Had two or fewer partners believed to be HIV-uninfected and who did not use illicit drugs (as defined above) and with whom he/she regularly used condoms for vaginal and anal intercourse;
• If sexually active female, willing to use one effective method of contraception (combined oral contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine Device (IUD); condoms; anatomical sterility in self or partner) at least until 3 months after last immunization. All female volunteers must be willing to undergo urine pregnancy tests at time points as indicated in the Schedule of Procedures.
• Confirmed HIV-1 or HIV-2 infection
• Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids immunosuppressive 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, myopericarditis, grand-mal epilepsy, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
• History of clinically significant eczema or chronic urticaria
• Any laboratory value outside of reference range, with the exception of any non-clinically significant Grade I elevations of liver function tests (AST, ALT, direct/total bilirubin), electrolytes (Na, K, Cl, CO2), CBC, urinalysis as determined by the Principal Investigator or his designee

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Study Officials

• Sarah Schlesinger, MD

  Rockefeller Univesrity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 28, 2013
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

US (1)