Clinical Trial 43291

Baltimore, MD 21201


Study Summary:

The Center for Vaccine Development and Global Health (CVD-GH) is conducting a study of an experimental universal mosquito-borne disease vaccine to investigate vaccine safety as well as how the vaccine affects both the human immune system response and the mosquito after mosquito bite exposure.

This is a Phase I randomized (like the flipping of a coin), double-blinded study (neither you nor the study team will know which study product you will receive).  We are studying the safety, reactivity and response of an investigational universal mosquito-borne disease vaccine given with or without an adjuvant (a substance that may help the vaccine work better) or placebo (salt water).  Each volunteer will receive two doses of vaccine 3 weeks apart.  Additionally, 3 weeks after the 2nd vaccination, participants will participate in a mosquito feeding with clean mosquitos (free from diseases) followed with small skin biopsies at and near the mosquito bite sites.

Your participation will extend over approximately 1 year, including 6 clinic visits (including the screening visit) and 4 phone calls.



Criteria:

 

  • 1.    You must be between 18 and 50 years of age. (inclusive)
  • 2.    You must provide written consent prior to any procedures, understand the study and be available for all the study visits over the 12-month study period.
  • 3.    If male: You must agree to practice abstinence or use a condom with spermicide plus ensure your female partner is using an acceptable form of birth control from 4 weeks before screening through 12 weeks after the 2nd vaccination. 
  • 4.    If female:  You must not be pregnant or breastfeeding along with one of the following:
  • a.    Of non-child-bearing potential (women who have had a hysterectomy or tubal ligation or are post-menopausal, as defined by no menses for > 1 year).
  • b.    Of child-bearing potential and agree to practice effective birth control or abstinence for 4 weeks before screening through 12 weeks after the 2nd vaccination.
  • Acceptable methods include a male partner who is sterile and is the sole sexual partner of the female participant or a male partner who uses a condom with spermicide plus 1 or more of the following:  1) implants of levonorgestrol (Norplant); 2) injectable progestogen (Depo-Provera); 3) Intrauterine Device (IUD); 4) oral contraceptives; 5) double barrier method (condom with diaphragm)
  • 5.    Must be willing to have samples stored for future research.
  • 6.    Must agree to abstain from alcohol intake for 24 hours before each study visit.
  • 7.    Must agree not to donate blood or blood products throughout the course of the study.
  • 8.    You must have a BMI of >18 and < 40.
  • 9.    You must have clinical lab results within the study-specific parameters stated in the protocol.  This is determined after screening blood work results are received.
  • 10. Must not have received blood or blood products including immunoglobulin within 3 months before study enrollment.
  • 11. Must not have received any unlicensed drug within 3 months before study enrollment or an unlicensed vaccine within 6 months of study enrollment.
  • 12. Must not have previously participated in the safety or immunogenicity testing of the AGS-v product.
  • 13. Must have no known or self-reported history of alcoholism or drug abuse within 6-months of study enrollment.
  • 14. Must not have any known or self-reported psychiatric or psychological issues that require treatment and are deemed by the study physician as exclusionary for study participation.
  • 15. Must not have a history of a severe allergic reaction or anaphylaxis.
  • 16. Must not have any known allergy to any vaccine component including adjuvants.
  • 17. Must not have a history of a severe vaccination reaction.
  • 18. Must not be severely allergic to mosquito bites (anaphylaxis).
  • 19. Must not have taken any oral, injected or intravenous corticosteroids of any dose in the 30 days prior to study vaccination (Day 1).
  • 20. Must not have taken any high-dose inhaled corticosteroids in the 30 days before study vaccination.
  • 21. Must not have received or plan to receive a licensed, live vaccine either 30 days before or after study vaccination or a licensed inactivated or killed vaccine either 14 days before or after study vaccination.
  • 22. Must not have known HIV, Hepatitis B virus or Hepatitis C virus.  This is included in the screening lab work.
  • 23. Must not have any current chronic skin condition or acute skin condition at the time of vaccination or mosquito feeding except mild eczema.
  • 24. Must not have a history of keloid formation after previous biopsies, lacerations, abrasions, surgeries, or other skin procedures (such as cosmetic piercings).


Qualified Participants May Receive:

Your compensation will be up to $1240 for completing all study-related visits.  A detailed study payment schedule is provided at the screening visit. 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.