Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®
Smallpox
Bottom Line
View on ClinicalTrials.gov: NCT01827371 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MVA Smallpox Vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Peak Plaque Reduction Neutralization Titer (PRNT) After Second Vaccination |
138.0; 55.1; 75.9; 103.5 | — |
| PRIMARY Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration |
28; 36; 26; 33; 6; 10 | 0.4782 |
| SECONDARY Geometric Mean Peak ELISA Titer After Second Vaccination |
1259.8; 741.4; 1021.0; 1351.8 | — |
| SECONDARY Number of Subjects Experiencing Serious Adverse Events (SAEs) Associated With IMVAMUNE |
1; 0; 1; 0 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- 18 to 40 years of age, inclusive.
- Read, signed, and dated informed consent document.
- Available for follow-up for the planned duration of the study (six months after last immunization).
- Acceptable medical history by screening evaluation and limited physical assessment.
- If the subject is female and of childbearing potential, negative serum or urine pregnancy test at screening and within 24 hours prior to vaccination.
- If the subject is female and of childbearing potential*, she agrees to practice abstinence** or use acceptable contraception*** through 56 days after the last vaccination in order to avoid pregnancy:
- a woman is considered of childbearing potential unless post-menopausal (>/= 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
**No sexual intercourse with men (vaginal penetration by a penis, coitus)
***Acceptable contraception methods are restricted to effective devices (IUDs, NuvaRing®) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, condoms with spermicidal agents, monogamous relationship with a vasectomized partner who has been vasectomized for 6 months or more prior to study entry, or successful Essure placement with documented confirmation test at least 3 months after the procedure, and any other FDA-approved contraceptive method
- Negative test for HIV.
- Alanine Aminotransferase (ALT) 3,800 and /=120,000/mm^3
- Body mass index >/=18.5- /= 150mmHg or diastolic blood pressure >/= 100mmHg.
- Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's (NCEP) risk assessment tool*
*NOTE that this criterion applies only to subjects 20 years of age and older AND only if at least one of the following apply:
- have smoked a cigarette in the past month, and/or
- have hypertension (defined as systolic blood pressure >140 mm Hg) or are on antihypertensive medication, and/or
- have a family history of coronary heart disease in male first-degree relative (father or brother) 5 mg prednisone or equivalent is considered high dose and immunosuppressive
- Corticosteroid nasal sprays for allergic rhinitis are permissible
- Persons who are using a topical steroid for mild uncomplicated dermatitis such as poison ivy or contact dermatitis may be enrolled the day after their therapy is completed
- Inhaled steroids for asthma are not permissible
- Oral/parenteral corticosteroids given for non-chronic conditions not expected to recur are permissible if the length of therapy was </= 14 days with completion at least 30 days prior to enrollment.
- Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol.
- Any history of illegal injection drug use.
- Receipt or planned receipt of inactivated vaccine from 14 days prior to the first vaccination through 14 days post second vaccination.
- Receipt or planned receipt of any other live attenuated vaccine within 30 days prior to the first vaccination through 30 days post second vaccination.
- Use of any other experimental agent within 30 days prior to vaccination and for the duration of the subject's participation in the study.
- Receipt of blood products or immunoglobulin, including Rhogam, within six months prior to vaccination.
- Donation of a unit of blood within 56 days prior to vaccination or planned donation prior to 28-days following the last vaccination.
- Pregnant or breastfeeding women.
- Active exfoliative skin disorders/conditions, current varicella zoster virus infection, or any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2×2 cm.
- Any condition that, in the opinion of the investigator, might interfere with assessing the study objectives.
- Known allergy to egg, aminoglycoside (including gentamicin) or c
Data sourced from ClinicalTrials.gov (NCT01827371). 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.