NCT01923610

Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

24 healthy male and female volunteers who are at low risk of HIV infection and entered into the RISVAC02 study and were randomly allocated to receive 3 intramuscular injections of MVA-B at weeks 0, 4 and 16 will receive a boosting dose 4 years thereafter. Participants will attend one of two clinical centres on at least 5 occasions over 16 weeks. These visits will comprise: * Screening * Trial entry and boosting immunisation * Early follow-up after immunisation * Follow-up x 2 including the final visit Participants will have blood and urine collected, and receive 1 immunisation. They will be counselled prior to and following a HIV test, and given health education on prevention of sexually transmitted infections including HIV. T The two centres which participate are: * Hospital Clinic, Barcelona and * Hospital Gregorio Marañón, Madrid The primary objective is to explore the safety and immunogenicity of MVA-B.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	Experimental	Biological/Vaccine: MVA-B Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef) -\~ 1 x 10e8 pfu/ml 3 immunisations at week 0, 4 and 16

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-08-15
• Last updated: 2017-03-21

Locations

2 sites across 1 country: Spain