Safety Study of an Additional MVA Vaccine in Volunteers Who Received 3 DNA Vaccines Followed by 2 MVA Vaccines

NCT01461447 | Completed Phase 1 DMC

• 1 other identifier: HIVIS 06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the safety and immunogenecity of a third MVA in the HIVIS 03 volunteers who have received 3 HIVIS DNA vaccines followed by boosting with 2 MVA vaccines. The investigators postulate that the Immune responses that were observed in the HIVIS 03 trial are likely to wane over time. To date it is unknown how these responses should best be maintained. In this study the investigators seek to boost immune responses, especially the antibody responses induced by the second MVA boost. Since the HIV specific antibodies were induced only after the second MVA injection, it is hypothesized that a 3rd MVA will give rise to even higher and sustained antibody titers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Proportion of volunteers with humoral and cellular immune responses elicited by 2 different immunization schedules (id or im DNA priming) prior to MVA boosting

  1 month after vaccination

• Safety assessed by the number of solicited and non solicited adverse events following immunization

  1 month after vaccination

Secondary Outcomes (1)

• Number of staff trained and able to conduct HIV-related vaccine studies at MUHAS.

  Two months

Study Arms (1)

MVA

EXPERIMENTAL

Volunteers who were primed with 3 HIVIS DNA and further boosted with 2 MVA vaccine will receive a third MVA there shall not be an comparator for this study.

Biological: Modified Vaccinia Ankara

Interventions

Modified Vaccinia Ankara BIOLOGICAL

Healthy volunteers will receive intramuscularly 1 injection of MVA-CMDR 1ml (Total 10 power 8 pfu) boost injection in the left deltoid muscle.

MVA

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have completed the HIVIS03/TaMoVac01 WP1 protocol and received the active vaccine
• Willing to undergo counseling and HIV testing
• Are not infected by HIV infection as indicated by a negative PCR reaction against HIV.
• Able to give informed consent
• Resident in Dar es Salaam, and willing to remain so for the duration of the study
• At low risk of HIV infection, defined as the absence of an identifiable risk factor/ behavior:
• sexual partner with HIV
• sexual partner with unknown HIV serostatus who is also unwilling to use protective condoms consistently in all sexual relations
• sexual partner is known to be at high risk for HIV
• more than one sexual partner in the last 6 months.
• history of being an alcoholic \[as medically defined or more than 35 units /week\]
• History of STI within past 6 months.
• Verbal assurances that adequate birth control measures are used not to conceive/father a child during the study and up to 4 months after the 3rd MVA vaccine injection
• Have a negative urinary pregnancy test for females
• ECG findings that neither pose a risk for the vaccination nor preclude evaluation of peri/myocarditis.

You may not qualify if:

• Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection. Such as detection of Hepatitis B surface antigen, or active syphilis.
• Have a history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
• Autoimmune disease by history and physical examination.
• Severe eczema
• Have history of psychiatric, medical and/or substance abuse problems during the past 6 months that the investigator believes would adversely affect the volunteer's ability to participate in the trial.
• History of grand-mal epilepsy, or currently taking anti-epileptics
• Have received blood or blood products or immunoglobulins in the past 3 months.
• Are receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy.
• Have used experimental therapeutic agents within 30 days of study entry.
• History of severe local or general reaction to vaccination defined as:
• Local: Extensive, indurated redness and swelling involving most of the major circumference of the arm, not resolving within 72 hours
• General: Fever \>= 39.5 0C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
• Are lactating mothers
• Are study site employees who are involved in the protocol and may have direct access to the immunogenicity results
• Unlikely to comply with protocol as judged by the principal investigator or her designate.

Sponsors & Collaborators

• Muhimbili University of Health and Allied Sciences: lead
• Karolinska Institutet: collaborator
• Swedish Institute for Infectious Disease Control: collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location

MeSH Terms

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 28, 2011
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 24, 2012

Record last verified: 2012-05

Locations

TA (1)