Healthy Volunteers HIV Vaccine - Washington DC

Summary:

A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health. The hypothesis is that sequential vaccination by a germline-targeting prime followed by directional boost immunogens can induce specific classes of B-cell responses and guide their early maturation toward broadly neutralizing antibody (bnAb) development through an mRNA platform. Fifty-six participants. Adults 18 to 50 years of age who meet all protocol inclusion criteria, who do not meet any protocol exclusion criteria, who understand the study (as demonstrated by the Assessment of [Informed Consent] Understanding [AOU]), and who can provide written informed consent. Randomization allocation is 16:16:16:8 for Groups 1-4 respectively.

There is no blinding in this study. Site and study staff will not be blinded to the IP.

How are study participants selected?

• You must be a healthy adult between 18 to 50 years of age (who has not yet reached their 51st birthday by the time of their vaccination) 
• You must be informed about this study and be able to answer questions about the study.
• You must be willing to give written consent to participate.
• You must be willing to adhere to the study protocol and be available for follow-up for the duration of the study.
• You must not be infected with HIV. 
• You must not have a history of myocarditis or pericarditis.
• You must agree to have an HIV test, undergo HIV risk reduction counseling and receive your HIV test results. 
• You must be at low risk for HIV infection as assessed by the clinic staff and maintain low-risk behavior for the duration of the study. 
• If born female and sexually active in a way that could lead you to get pregnant, you must not be pregnant or breastfeeding, and you must be willing to use an effective method of contraception two weeks before the first study vaccination and until 4 months after the last study vaccination and have pregnancy tests throughout the study. 
• If born male, you should use effective birth control (male condoms) and not make a woman pregnant from the day of the first study vaccination until at least 4 months after the last study  vaccination  (unless  anatomically  sterile  or  in  a  monogamous  relationship  with  a female partner who uses a documented method of birth control).
• You must be willing to not donate blood, or any other tissues during the study.  
• Any  COVID-19  (SARS-CoV-2)  vaccination  series  must  have  been  completed  at  a minimum of 1 month (28 days) before receiving any dose of investigational vaccine in this study.
• You  must  not  receive  a  booster  dose  of  a  COVID-19  mRNA  vaccine  (e.g.,  Pfizer  or Moderna) within 28 days before or after getting a study vaccine, or receive a booster dose of a COVID-19 adenoviral-vectored (e.g., Johnson & Johnson) or protein vaccine within 14 days before or after receiving a dose of study vaccine, with the intention of prioritizing COVID-19 vaccination over all other considerations.

Qualified Participants May Receive:

There are two study vaccines for this clinical trial, eOD-GT8 60mer mRNA and Core-g28v2 60mer mRNA Vaccines. You might receive one or both in combination. The  eOD-GT8  60mer  mRNA  and  Core-g28v2  60mer  mRNA  vaccines  both  include  a  short segment of messenger ribonucleic acid (mRNA). The mRNA is a genetic code that tells cells how to make a protein. For both the HIV vaccines being tested in this study, the mRNA encodes for a protein that is designed to look and behave like the envelope protein, the protein that sits on top of the outer surface of HIV, the virus that causes AIDS. The mRNA is entirely made in a laboratory. When injected into the body, the mRNA causes some cells to make that viral protein, which can trigger an immune response. If the person is later infected, their immune system remembers the protein from the prior vaccination which may help it to fight the invading virus. The mRNA vaccines degrade naturally and do not persist in the body.In animal testing, eOD-GT8 60mer mRNA and Core-g28v2 60mer mRNA Vaccines have been shown  to  be  safe  and  able  to  start  the  body’s  immune  system  along  the  pathway  to  make antibodies against the HIV virus.The study vaccines are mixed with saline before being injected.

It is absolutely IMPOSSIBLE to get HIV infection or AIDS from these vaccines.

Will I be paid for my participation in research?If  you  agree  to  take  part  in  this  research  study,  we  will  pay  you  for  every  study  visit  that  you complete. This will cover your time, inconvenience, and travel expenses to and from the study clinic. You will be given $125 for each vaccination visit, $75 for each leukapheresis visit, and $50 for all other in-clinic visits. You will be given $25 for scheduled telephone, text, or email contacts. Depending on which group you are assigned to, you may receive between $625 and $1350 in total for attending all study visits. The study vaccine(s), study-related tests and visits are free of charge to you.