Phase 2
N=581
Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00316589 ↗Enrolled (actual)
581
Serious AEs
4.0%
Results posted
Jan 2019
Primary outcome: Primary: Serious Adverse Events — 0; 17; 0; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IMVAMUNE (MVA-BN) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bavarian Nordic
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serious Adverse Events |
0; 17; 0; 6; 0; 15 | — |
| SECONDARY Related Grade >=3 Adverse Events |
7; 26; 0; 5 | — |
| SECONDARY Solicited Local Adverse Events |
79; 246; 7; 79; 9; 28 | — |
| SECONDARY Solicited General Adverse Events |
9; 26; 1; 15; 5; 17 | — |
| SECONDARY Unsolicited Adverse Events: Incidence |
59; 236; 3; 73 | — |
| SECONDARY Unsolicited Adverse Events: Intensity |
149; 590; 6; 175; 113; 410 | — |
| SECONDARY Unsolicited Adverse Events: Relationship to Vaccination |
45; 236; 0; 87; 40; 167 | — |
| SECONDARY CD4+ T-cell Counts |
445.0; 456.0; 434.5; 455.0; 438.5; 447.0 | — |
| SECONDARY CD8+ T-cell Counts |
771.0; 877.5; 779.0; 848.0; 749.0; 798.5 | — |
| SECONDARY Viral Load |
13; 5; 262; 112; 11; 3 | — |
| SECONDARY PRNT Seroconversion Rate |
5.3; 14.5; 60.0; 45.1; 17.5; 21.6 | — |
| SECONDARY PRNT GMT |
1.3; 2.0; 12.0; 5.5; 1.6; 2.9 | — |
| SECONDARY ELISA Seroconversion Rate |
24.6; 29.5; 80.0; 58.2; 80.7; 69.3 | — |
| SECONDARY ELISA GMT |
1.9; 4.6; 37.1; 33.3; 3.7; 9.4 | — |
| SECONDARY ELISPOT IFN-γ: Response Rate |
39.1; 28.6; 0.0; 26.5; 39.1; 20.0 | — |
| SECONDARY ELISPOT IFN-γ: SFU |
0.0; 0.0; 155.0; 0.0; 87.0; 0.0 | — |
Summary
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations
Eligibility Criteria
- Genders eligible for Study: Both
- Age: between 18 and 55 years
- Healthy volunteers are accepted
Inclusion Criteria
- Subjects tested positive for HIV-1 infection (HIV-infected subjects).
- Subjects that are tested negative for HIV (Healthy subjects).
- Either on stable antiretroviral therapy or not on antiretroviral therapy.
- CD4 cells > = 200 - 750/µl.
- Subjects must be in good general health except for HIV infection.
- Women must not be pregnant and use an acceptable method of contraception.
Exclusion Criteria
- Impairment of immunologic function (other than HIV infection).
- History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
- Uncontrolled serious infection.
- History of or active autoimmune disease.
- History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
- History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years.
- High risk of developing a myocardial infarction or coronary death.
- History of intravenous drug abuse (within the last 12 months).
- Known allergy to egg or aminoglycoside (gentamicin).
- History of anaphylaxis or severe allergic reaction.
- Subjects undergoing treatment for tuberculosis infection or disease.
- Chronic administration of systemic immuno-suppressants.
Data sourced from ClinicalTrials.gov (NCT00316589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.