SmallpoxPhase 2NCT00050518
APSV in Vaccinia Naive Adults
A Phase 2 study testing Aventis Pasteur Smallpox Vaccine in people with Smallpox, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
The study seeks to define, with precision, the safety and efficacy of APSV, two dose potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a classic �take� as defined by formation of a lesion at the injection site consistent with the �Jennerian� process (see Appendix A) and vaccine… Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- Aventis Pasteur Smallpox Vaccine
- Type of treatment
- Vaccines
- How many people
- 444 participants
- Where
- 4 sitesUnited States
- Study dates
- Start not givento Feb 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adequate renal function defined as a serum creatinine 1.5 mg/dL; urine protein < 100mg/ dL or trace or negative proteinuria (by dipstick), and a calculated creatinine clearance >55 mL/min. Formula for calculations is contained within the Manual of Procedures.
- (Note: Renal function is measured to ensure that subjects could meet criteria for use of cidofovir if needed).
- Age 18-32 (children are excluded due to concerns of safety, including autoinoculation).
- Willing to sign informed consent.
- Availability for follow-up for planned duration of the study (56 days following the last vaccination).
- Acceptable medical history by screen evaluation form and brief assessment.
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- Absence of a typical vaccinia scar and negative history of smallpox vaccination.
- Negative urine or serum pregnancy test for women of childbearing potential.
- If the volunteer is female and of childbearing potential, she agrees to use acceptable contraception, and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).
- Negative ELISA for HIV or negative Western blot for subjects who have a positive ELISA and have participated in an HIV vaccine trial.
- Negative hepatitis B surface antigen and negative antibody to hepatitis C virus.
- Negative urine glucose by dipstick.
- ALT < 1.5 times institutional upper limit of normal.
Who cannot join
- Allergies to any component of the vaccines (e.g., polymyxin B sulfate, dihydrostreptomycin sulfate, chlorotetracycline hydrochloride).
- History of immunodeficiency.
- Serology positive for HIV, hepatitis B, or hepatitis C at the screening visit.
- Known or suspected impairment of immunologic function including, but not limited to clinically significant liver disease.
- Diabetes mellitus.
- Moderate to severe kidney impairment.
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- Malignancy with the exception of squamous cell or basal cell skin cancer.
- Autoimmune disease.
- Use of immunosuppressive medication.
- Corticosteroid nasal sprays are permissible.
- Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol.
- History of illegal injection drug use.
- Live attenuated vaccines within 60 days of study.
- Use of experimental agents within 30 days prior to study.
- Any history of vaccination with any vaccinia vectored or other pox vectored experimental vaccine.
- Smallpox vaccination since 1990 (Vaccinia experience cohorts).
- Typical vaccinia scar or history of smallpox vaccination (Vaccinia naive cohorts only).
- Receipt of blood products or immunoglobulin in the past 6 months.
- Recent donation of the equivalent of a pint of blood within the 30 days prior to enrollment.
- Acute febrile illness (100.5 F) on the day of vaccination.
- Pregnant or lactating women.
- Eczema of any degree or history of eczema.
- History of exfoliative skin disorders/conditions.
- Any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2x2 cm.
- Household contacts/sexual contacts with, or close and frequent occupational exposure to, any of the following: pregnant women, children < 12 months of age, people with eczema or history of eczema, people with any of the skin disorders/conditions previously listed, people with immunodeficiency disease or use of immunosuppressive medications.
- Any condition which, in the opinion of the investigator, might interfere with study objectives.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cincinnati Children's Hospital Med Ctr
Cincinnati, Ohio, 45229
University of Cincinnati
Cincinnati, Ohio, 45267-05
University of Iowa - Iowa City IA
Iowa City, Iowa, 52242
Vanderbilt University
Nashville, Tennessee, 37232-26
About this study
Official title: A Multicenter, Double-Blind, Randomized Study of the Safety and Efficacy of Aventis Pasteur's Smallpox Vaccine, USP (APSV) in Vaccinia-Naive Adults.
The study seeks to define, with precision, the safety and efficacy of APSV, two dose potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a classic �take� as defined by formation of a lesion at the injection site consistent with the �Jennerian� process (see Appendix A) and vaccine specific immune responses will be assessed. The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of live, replicating smallpox vaccines. Neutralizing antibody formation has been correlated with takes for the Dryvax vaccine and is considered to be cross-protective for other orthopoxviruses, including variola. The study also seeks to characterize preliminarily the cell mediated immune (CMI) response to APSV (as compared to Dryvax).
Read the detailed description
A Multicenter, double blind, randomized trial in which each volunteer will receive one of 2 dose concentrations of one of two lots of Aventis Pasteur Smallpox Vaccine as a single vaccination (undiluted, 1:5 dilution). Volunteers without a take at day 7 - 9 will be offered a vaccination with Dryvax at the end of the study.
- Conditions
- Smallpox
- Being tested
- Aventis Pasteur Smallpox Vaccine
- Keywords
- Smallpox, Aventis Pasteur, Vaccine
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aventis Pasteur Smallpox VaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2002 (estimated)
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmallpoxStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 444 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050518
- Sponsor's protocol ID
- 02-054
- Status last verified
- Mar 2010
- First submitted
- 11 Dec 2002
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized Study of the Safety and Efficacy of Aventis Pasteur's Smallpox Vaccine, USP (APSV) in Vaccinia-Naive Adults.
- ClinicalTrials.gov ID
- NCT00050518
- Acronym / sponsor ID
- 02-054
- Conditions
- Smallpox
- Keywords
- Smallpox, Aventis Pasteur, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 13 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study seeks to define, with precision, the safety and efficacy of APSV, two dose potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a classic �take� as defined by formation of a lesion at the injection site consistent with the �Jennerian� process (see Appendix A) and vaccine specific immune responses will be assessed. The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of live, replicating smallpox vaccines. Neutralizing antibody formation has been correlated with takes for the Dryvax vaccine and is considered to be cross-protective for other orthopoxviruses, including variola. The study also seeks to characterize preliminarily the cell mediated immune (CMI) response to APSV (as compared to Dryvax).
Detailed description
A Multicenter, double blind, randomized trial in which each volunteer will receive one of 2 dose concentrations of one of two lots of Aventis Pasteur Smallpox Vaccine as a single vaccination (undiluted, 1:5 dilution). Volunteers without a take at day 7 - 9 will be offered a vaccination with Dryvax at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Adequate renal function defined as a serum creatinine 1.5 mg/dL; urine protein < 100mg/ dL or trace or negative proteinuria (by dipstick), and a calculated creatinine clearance >55 mL/min. Formula for calculations is contained within the Manual of Procedures.
- (Note: Renal function is measured to ensure that subjects could meet criteria for use of cidofovir if needed).
- Age 18-32 (children are excluded due to concerns of safety, including autoinoculation).
- Willing to sign informed consent.
- Availability for follow-up for planned duration of the study (56 days following the last vaccination).
Key exclusion criteria (26 listed)
- Allergies to any component of the vaccines (e.g., polymyxin B sulfate, dihydrostreptomycin sulfate, chlorotetracycline hydrochloride).
- History of immunodeficiency.
- Serology positive for HIV, hepatitis B, or hepatitis C at the screening visit.
- Known or suspected impairment of immunologic function including, but not limited to clinically significant liver disease.
- Diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aventis Pasteur Smallpox Vaccine | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aventis Pasteur Smallpox Vaccine in people with Smallpox, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010.