HealthyPhase 1/2NCT00263744
Study to Evaluate the Safety and Immunogenicity of MEDI-517P in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive
A Phase 1/2 study testing MEDI 517 and Aluminum hydroxide in people with Healthy, run by MedImmune LLC.
Trial summary
The primary objective of this study is to describe the safety of 40 mg MEDI-517, with a control of aluminum hydroxide, when given to healthy adult women who have evidence of HPV-16 and/or HPV-18 DNA detected in cervical brushings. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MEDI 517 and Aluminum hydroxide
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 1999to Jun 2001
- Phase
- Phase 1/2
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 18 through 30 years of age (must not have reached the 31st birthday)
- Unless previously surgically sterilized, agrees to use an effective method of birth control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, Norplant® or DepoProvera®) beginning 30 days before the first study injection and continuing through 60 days after the final study injection
- Healthy by medical history and physical examination
- Cervical specimen positive for HPV-16 and/or HPV-18 DNA using the Digene Hybrid Capture® II HPV test within 21 days of study entry
- Cervical cytology by Pap smear that is either normal or no greater than ASCUS or AGCUS, using the Cytyc ThinPrep® Pap Test, within 21 days of study entry (a normal Pap smear must also be adequate for interpretation; a Pap smear that is normal but inadequate for interpretation must be repeated). Those volunteers with ASCUS or AGCUS must have had a clinical evaluation by colposcopy within the previous month which showed no evidence of CIN or SIL.
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- No evidence of anogenital HPV lesions or no physical findings suggestive of other gynecologic pathogens on pelvic examination within 21 days of study entry
- Agrees to no other experimental therapy or vaccines until 30 days after the last study injection
- Written informed consent obtained from the volunteer
Who cannot join
- Acute illness or fever (oral temperature ³99.5°F [37.5°C]) at start of the study
- History or clinical manifestations of significant medical or psychiatric disorder
- Pregnant or lactating
- Use of immunosuppressive medication (inhaled and topical corticosteroids are permitted) within the previous 90 days or history of immunodeficiency
- History of cancer
- History of alcohol or drug abuse within the past 2 years
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- At screening (must be within 21 days of study entry) any of the following: hemoglobin <11 gm/dL; white blood cell count <4000/mm3; platelet count <120,000/mm3; AST, ALT, creatinine >1.5x upper limit of normal for the laboratory in question; other abnormal laboratory values in the screening panel which in the opinion of the principal investigator are judged to be clinically significant
- Receipt of immunoglobulin or blood products within 90 days prior to study entry
- History of Pap smear more severe than ASCUS or AGCUS
- Positive tests for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 antibody
- Any prior receipt of any vaccine or therapy (experimental or otherwise) for treatment or prophylaxis of genital warts or other papillomavirus related condition. Any treatment of genital warts or other papillomavirus related condition within six months of randomization (local therapy for common skin and/or plantar warts is allowed)
- Prior receipt of any vaccine containing monophosphoryl lipid A or SBAS4 adjuvant (no vaccines currently licensed contain these)
- Receipt of any experimental vaccine within 90 days prior to entry into this study
- Receipt of any experimental drug therapy within 30 days or five half-lives of the experimental drug (if the half-life is known), whichever is longer
About this study
Official title: A Phase I/II Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus (HPV) Types 16 and 18, in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive
The primary objective of this study is to describe the safety of 40 mg MEDI-517, with a control of aluminum hydroxide, when given to healthy adult women who have evidence of HPV-16 and/or HPV-18 DNA detected in cervical brushings.
- Conditions
- Healthy
- Being tested
- MEDI 517, Aluminum hydroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI 517Biological
Vaccine is supplied in single use vials containing 0.75 mL of MEDI-517 at a concentration of 40 mg/0.5 mL formulated with SBAS4 adjuvant.
Aluminum hydroxideOther
Aluminum hydroxide supplied in single use vials containing 0.75 mL of aluminum hydroxide at a concentration of 0.5 mg of aluminum in the form of aluminum hydroxide per 0.5 mL.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI517 Receives: Biological: MEDI 517 |
| 2 | Active comparator | Aluminum hydroxide Receives: Other: Aluminum hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety in terms of unsolicited adverse events and serious adverse events.
Measured: 7 days after each injection
Secondary outcomes (1)
Determine the effect of MEDI-517 compared to aluminum hydroxide control on the proportion of volunteers who are positive for HPV DNA.
Measured: Swab taken on Study Day 210
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2005 (estimated)
- Study startNov 1999
- Primary completionApr 2001
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Investigators
- Genevieve Losonsky, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263744
- Sponsor's protocol ID
- MI-CP058
- Status last verified
- Jan 2009
- First submitted
- 8 Dec 2005
- Last updated
- 8 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus (HPV) Types 16 and 18, in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive
- ClinicalTrials.gov ID
- NCT00263744
- Acronym / sponsor ID
- MI-CP058
- Conditions
- Healthy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 1999
- Primary completion
- Apr 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 9 Dec 2005 (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 primary objective of this study is to describe the safety of 40 mg MEDI-517, with a control of aluminum hydroxide, when given to healthy adult women who have evidence of HPV-16 and/or HPV-18 DNA detected in cervical brushings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MEDI 517MEDI517 |
| 2 | Active comparator | Other: Aluminum hydroxideAluminum hydroxide |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Female
- 18 through 30 years of age (must not have reached the 31st birthday)
- Unless previously surgically sterilized, agrees to use an effective method of birth control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, Norplant® or DepoProvera®) beginning 30 days before the first study injection and continuing through 60 days after the final study injection
- Healthy by medical history and physical examination
- Cervical specimen positive for HPV-16 and/or HPV-18 DNA using the Digene Hybrid Capture® II HPV test within 21 days of study entry
Key exclusion criteria (14 listed)
- Acute illness or fever (oral temperature ³99.5°F [37.5°C]) at start of the study
- History or clinical manifestations of significant medical or psychiatric disorder
- Pregnant or lactating
- Use of immunosuppressive medication (inhaled and topical corticosteroids are permitted) within the previous 90 days or history of immunodeficiency
- History of cancer
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 |
|---|---|---|
| MEDI 517Vaccine is supplied in single use vials containing 0.75 mL of MEDI-517 at a concentration of 40 mg/0.5 mL formulated with SBAS4 adjuvant. | Biological | 1 |
| Aluminum hydroxideAluminum hydroxide supplied in single use vials containing 0.75 mL of aluminum hydroxide at a concentration of 0.5 mg of aluminum in the form of aluminum hydroxide per 0.5 mL. | Other | 2 |
Primary outcome
Evaluation of safety in terms of unsolicited adverse events and serious adverse events.
Time frame: 7 days after each injection
1 secondary outcome
Determine the effect of MEDI-517 compared to aluminum hydroxide control on the proportion of volunteers who are positive for HPV DNA.
Time frame: Swab taken on Study Day 210
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 8 Jan 2009.
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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.
Genevieve Losonsky, M.D. study director
MedImmune LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MEDI 517 and Aluminum hydroxide in people with Healthy, run by MedImmune LLC.
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 9 inclusion and 14 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 8 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Evaluation of safety in terms of unsolicited adverse events and serious adverse events. (time frame: 7 days after each injection). It is what the study was designed to measure, not a finding.
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 8 Jan 2009.