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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923610
• Other study ID #: RisVac02 boost
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2013
• Last updated: March 20, 2017
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: March 2017
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• male or female

• age between 18 and 55 years on the day of screening

• available for follow-up for the duration of the study (52 weeks from screening)

• able to give written informed consent

• at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as: no history of injecting drug use in the previous ten years no gonorrhoea or syphilis in the last six months no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months no unprotected anal intercourse in the last six months no unprotected vaginal intercourse outside a relationship with a regular known/presumed HIV negative partner in the last six months

• willing to undergo a HIV test

• willing to undergo a genital infection screen

• if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; IUCD; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination

• if heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination

Exclusion Criteria:

• positive for hepatitis B surface antigen, hepatitis C antibody, antibody responses to vaccinia or serology indicating active syphilis requiring treatment

• pregnant or lactating

• clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, immunodeficiency or use of immunosuppressives in preceding 3 months

• receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment

• receipt of blood products or immunoglobin within 4 months of screening

• participation in another trial of a medicinal product, completed less than 30 days prior to enrolment

• history of severe local or general reaction to vaccination defined as local:

extensive, indurated redness and swelling involving most of the front-lateral thigh or the major circumference of the arm, not resolving within 72 hours general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal

• HIV 1/2 positive or indeterminate on screening

• positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment

• grade 1 routine laboratory parameters

• unlikely to comply with protocol

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona	Catalunya
Spain	Hospital Universitario Gregorio Marañón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local adverse event	Grade 3 or above local adverse event (pain, cutaneous reactions including induration)	12 weeks
Primary	Grade 3 or above systemic adverse event	Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia)	12 weeks
Primary	Grade 3 or above other clinical or laboratory adverse event	Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively	12 weeks
Primary	Event attributable to vaccine leading to discontinuation	Any event attributable to vaccine leading to discontinuation of the immunisation regimen	12 weeks
Primary	Primary immunogenicity parameters	The primary immunogenicity parameters will be quantitative or present/absent, and are cellular responses - CD8/CD4+ T cell responses (ELISPOT) at week 2, 4 and 12 following the immunisations	12 weeks
Secondary	All grade 1 and 2 adverse events		28 days of vaccination
Secondary	Antibody responses	binding titration to the construct MVAB; binding titration to and neutralisation of vaccinia	12 weeks
Secondary	cellular responses	CD8/CD4+ T cell responses (ELISPOT) at week 0; intracellular cytokine analysis at week 0, 2, 4 and 12	12 weeks