HIV
Conditions
Keywords
HIV Prevention
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.
Detailed description
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. Investigators propose to assess the quality of immunity elicited by immunizations with MVA-CMDR only or by booster immunizations with MVA-CMDR in volunteers previously immunized with a DC-targeted HIV vaccine. This vaccination regimen can provide the proof-of-concept that DC targeted protein vaccines can prime strong immune responses and therefore be valuable in combination with other vaccine modalities against HIV or other diseases.
Interventions
BIOLOGICALMVA-CMDR
injections of MVA-CMDR vaccine
Sponsors
Rockefeller University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 62 Years
Healthy volunteers
Yes
Inclusion criteria
* Have completed protocol SSC-710 and received either DCVax-001 plus poly ICLC, poly ICLC only or sterile saline. If less than 6 volunteers who originally received placebo (poly ICLC only or sterile saline) under protocol SSC\_710 are willing to participate and are found eligible to participate in this proposed study, new volunteers can be enrolled as long as they are eligible according to the remaining inclusion and
Exclusion criteria
below. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety and tolerability of MVA-CMDR vaccine | 16 weeks | safety and tolerability of two intramuscular injections of MVA-CMDR vaccine candidate in healthy HIV-uninfected volunteers |
Countries
United States
Outcome results
None listed