Safety, Tolerability, and Immunogenicity of ALFQ in a HIV Vaccine Containing A244 and B.65321 in Healthy Adults

Exclusion Criteria

• •1. Receipt of any investigational HIV vaccine or investigational adjuvant
• •2. Received an investigational product in the 30 days before enrollment, or planned to receive during the study period. This does not include products with emergency use authorization.
• •3. Concurrent participation in another clinical research study
• •4. Any serious medical illness or condition
• •5. Receipt of immunoglobulins or blood products within 3 months before enrollment
• •6. Any history of anaphylaxis or allergy to study product
• •7. History of sickle cell trait or disease
• •8. Pregnancy, lactation, or intention to become pregnant during the study
• •9. History of active/recent cancer still within treatment or active surveillance follow-up (except basal cell carcinoma of the skin and cervical carcinoma in situ). Treated/resolved cancers with no likelihood of recurrence may be deemed acceptable at Principal Investigator (PI) discretion.
• •10. History of autoimmune disease
• •11. History of Potentially Immune-Mediated Medical Conditions (PIMMCs)
• •12. Suspected or known current alcohol or drug abuse as defined by an alcohol intake of greater than 3 drinks a day on average for a man, and greater than 2 drinks a day on average for a woman
• •13. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to give informed consent, participate in the study, or impair interpretation of the study data, in the opinion of the Investigator
• •14. History of splenectomy
• •15. History of confirmed or suspected immunodeficiency
• •16. History of hereditary angioedema (HAE) acquired angioedema (AAE), or idiopathic forms of angioedema
• •17. History of asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years
• •18. History of diabetes mellitus (type I or II), with the exception of gestational diabetes
• •19. History of thyroid disease (except for well controlled hypothyroidism)
• •20. History of idiopathic urticaria within the past year
• •21. History of hypertension that is not well controlled by medication or that is persistently greater than 140/95 at screening
• •22. History of bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
• •23. History of chronic or active neurologic disease to include seizure disorder and chronic migraine headaches. Exceptions are: i) childhood febrile seizures, or ii) seizures secondary to alcohol withdrawal more than 3 years ago
• •24. Subjects receiving any of the following substances:
• •1. Systemic immunosuppressive medications or cytotoxic medications within 12 weeks before enrollment \[with the exception of a short course of corticosteroids (≤ 14 days duration or a single injection) for a self-limited condition at least 2 weeks before enrollment; inhaled, intranasal or topical steroids are not considered exclusionary
• •2. Treatment with known immunomodulators including allergy immunotherapy (other than nonsteroidal anti-inflammatory drugs \[NSAIDs\] or stable maintenance immunotherapy (doses not in the process of being increased), at the discretion of the Protocol Safety Review Team (PSRT)) for any reason
• •3. Live attenuated vaccines within 30 days before initial study vaccine administration
• •4. Medically indicated subunit, messenger ribonucleic acid (mRNA), or killed vaccines, e.g., influenza, pneumococcal, vaccines with Quillaja saponaria-21 (QS-21) as an adjuvant, or allergy treatment with antigen injections, planned for administration 14 days before or after study vaccine administration
• •25. History of arthritis diagnosis other than osteoarthritis
• •26. History of other diagnosed rheumatoid disorders
• •27. Has an acute illness or temperature ≥38.0 degrees Celsius (C)/100.4 degrees Fahrenheit (F) on any study injection day or within 48 hours of planned study injection.
• •Note: Participants will not be excluded from further consideration for enrollment and study injections. Volunteers with fever or an acute illness on the day of study injection or in the 2 days before the study injection may be re-assessed by a study physician for resolution of the condition and enrolled and receive the study injection so long as the injection is within allowable windows. Military personnel will be excluded from participation in this study, regardless of leave status due to the potential for a false-positive HIV test result on mandatory HIV testing. This could have adverse effects on deployment status.
• •Final evaluation of eligibility will be based on the medical judgment of the investigator based on his/her medical and research experience.