Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Healthy, HIV-Negative, Adult Volunteers wanted for an HIV-Vaccine study

We are doing this research study to find out if the study vaccine, BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, is safe and tolerable and to test how your immune system responds to it.

Massachusetts General Hospital HIV HIV Medicines Healthy Living
20 visits over 20 months
Estimated Time Commitment
Male, Female, Transgender Female, Transgender Male, 18-50 years
May Be Eligible
Payment up to $1,600
May Be Offered
Blood draw, Injection or IV, Office visit, Ultrasound, Personal health tracking
May Be Required
 
I Am Interested I Am Interested I Am Interested

This project is not recruiting.

Overview

What we are studying

This is a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy, adult, HIV-negative volunteers.


Why it is important

Since the start of the HIV/AIDS epidemic, more than 76 million people have been infected with HIV and 35 million people have died of AIDS-related illnesses. In 2016, there were approximately 36.7 million people living with HIV, 1.8 million new HIV infections, and 1.0 million deaths attributable to HIV. Although access to antiretroviral therapy (ART) has increased, in 2016 about 53% of people living with HIV had access to treatment. For these reasons, it is clear that antiretroviral therapy is effective but not sufficient to end the global AIDS epidemic; ultimately a vaccine would be the most effective option to control and eradicate this infectious disease.


What we hope to accomplish

To evaluate the safety and tolerability of intramuscular administration of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults. To determine the immunogenicity of the HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in HIV-uninfected adults.

Principal Investigator

Boris Juelg, MD, PhD

Massachusetts General Hospital

Public Profile

Who can participate


  • Healthy male and female, including transgender individuals, as assessed by a medical history, physical exam, and laboratory tests

  • At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of first vaccination

  • Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study

  • In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and/or risks linked to vaccination and participation in the trial

  • Willing to undergo HIV testing, risk reduction counseling and receive HIV test results

  • All individuals born female engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception for 4 months following investigational product administration

  • All volunteers born female, who are not heterosexually active at screening

  • All volunteers born female must be willing to undergo urine pregnancy tests

  • All sexually active volunteers born male, regardless of reproductive potential, must be willing to use an effective method of contraception from the day of first vaccination until at least 4 months after the last vaccination

  • Willing to forgo donations of blood, or any other tissues during the study


Healthy Volunteers

Healthy volunteers are eligible for this study

Healthy male and female, including transgender individuals, as assessed by a medical history, physical exam, and laboratory tests.

Who cannot participate


  • Confirmed HIV-1 or HIV-2 infection

  • Any clinically relevant abnormality in history or upon examination including history of immunodeficiency or autoimmune disease

  • Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator makes the volunteer unsuitable for participation in the study

  • Reported risky behavior for HIV infection within 12 months prior to vaccination

  • If female, pregnant or planning a pregnancy during the period of enrollment until 4 months after the last study vaccination

  • Bleeding disorder that was diagnosed by a physician

  • Infectious disease: chronic hepatitis B infection, current hepatitis C infection, HCV Ab positive and HCV RNA positive, treatment for chronic hepatitis C infection in the past year, or active syphilis

  • History of splenectomy

  • Any of the following abnormal laboratory parameters listed below:

    • Hematology

    • Chemistry

    • Urinalysis



  • Receipt of live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccination with Investigational Product; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product. (Exception is live attenuated influenza vaccine within 14 days)

  • Receipt of blood transfusion or blood-derived products within the previous 3 months

  • Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study

  • Prior receipt of another investigational HIV vaccine candidate or HIV monoclonal antibody 

  • History of severe local or systemic reactogenicity to vaccines 

  • Psychiatric condition that compromises safety of the volunteer and precludes compliance with the protocol

  • Seizure disorder

  • A history of malignancy in the past 5 years (prior to screening) or ongoing malignancy 

  • Active, serious infections requiring parenteral antibiotic, antiviral or antifungal therapy within 30 days prior to enrollment

  • Body mass index (BMI) >/= to 35

  • Body weight <110 pounds (55 kg)

  • If, in the opinion of the Principal Investigator, it is not in the best interest of the volunteer to participate in the trial

  • NSAID/Aspirin use that cannot be held for 5 days prior to the leukapheresis procedure

What you may be asked to do

If you join the study, you will have responsibilities. It is important that you:



  • Come to all study visits and follow the study instructions.

    • Study visit procedures throughout the study will include:

      • Blood draw

      • Urine sample

      • Urine pregnancy test (females only)

      • Physical examination (including height and weight)

      • Assessment of vital signs (pulse, respiratory rate, blood pressure, and temperature)

      • Review of medical history including medication and sexual behavior

      • Counselling on family planning and contraceptives, HIV risk factors and transmission, and ways to decrease chances of obtaining HIV

      • Leukapheresis procedure (collection of only white blood cells) OR large volume blood draw (collection of whole blood)

      • Intramuscular administration of study vaccine OR placebo

      • Fine Needle Aspirate (FNA) procedure (sampling of lymph node tissue)

      • Follow-up outpatient visits and follow-up phone/e-mail visits





  • Be informed about the study and ask questions if you don’t understand something.

  • Give staff complete and accurate study-related information including your medical history and any medications you are taking.

  • Update the staff about any symptoms or illnesses you are experiencing. 

  • Inform the staff of any problems or discrimination you experience because of your participation in the study.

  • Receive HIV testing only at the clinic during the study as required by the study procedures.

  • Use birth control methods as described earlier.

  • Stay in touch with us. Tell us if your address, phone number, or email address changes, if you are moving away, or if you want to leave the study.


You should not:



  • Donate blood.

  • Donate body parts, body fluids, or body tissues without talking to the study staff first.

  • Receive any experimental medication or vaccinations other than our study product.

  • Join another research study without talking to the study staff first.


Project activities may include:

  • Blood draw
  • Injection or IV
  • Office visit
  • Ultrasound
  • Personal health tracking

Estimated Time Commitment

20 visits over 20 months

What You May Get

You will not directly benefit from taking part in this study. We hope the information learned from this study will help further the development of HIV-vaccine, which may benefit patients with HIV in the future. It is possible that taking part in this study may inform you more about HIV-vaccine clinical research in general, should you consider to take part in other studies in the future. You may receive information about your health because of the physical examinations and medical tests done in this study.


We will pay you $1,600 if you complete the study.


If you do not complete the study, the amount you are paid will be based on visits completed. You will be paid after each completed visit. You will recieve $50 for completing the screening visit. For each Leukaphereis visit completed you will recieve $200 and for each FNA visit completed you will recieve $200.You will recieve $50 for each follow-up visit and follow-up phone/e-mail visit completed.

Location

Massachusetts General Hospital- White 12
55 Fruit Street, Boston, MA, 02114

Map it!


Travel

  • Accessible by public transportation
  • Parking available

Travel and Parking Details

Additional Information

ClinicalTrials.gov Identifier

NCT03699241


Study Phase

Phase 1: This project studies the safety of a medication or treatment, usually on healthy volunteers. It examines the medication or treatment’s effects on the body and looks for side effects.


Participating Institutions


Funding Source

  • Other
Top