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Tests treatment safety and results for Healthy Volunteer
Official title Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers
ClinicalTrials.gov ID: NCT03878121
What this study is testing
What is Ad4-Env145NFL?
Ad4-Env145NFL is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy volunteer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- All participants (vaccinees, household contacts, and intimate contacts) must meet all of the following criteria:
- Age 18 to 49 years for vaccinees. Age 18 to 65 years for household and intimate contacts.
- Negative FDA-approved HIV test.
- Available and willing to participate in follow-up visits and tests for the duration of the study.
- Willing to have samples stored for future research. The following apply to vaccinees and intimate contacts, but not to household contacts:
You likely can't join if
- A participant (vaccinees, household contacts, and intimate contacts) will be excluded if they have the following: 1\. Any condition that, in the...
- History of any prior disease or therapy which would affect immune or pulmonary function.
- Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of radiation therapy or cytotoxic/cancer chemotherapy.
- History of uncontrolled diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c \<= 8% within the last 6 months) or a...
- Immunodeficiency or autoimmune disease.
See the full eligibility criteria
Who can join
- All participants (vaccinees, household contacts, and intimate contacts) must meet all of the following criteria:
- Age 18 to 49 years for vaccinees. Age 18 to 65 years for household and intimate contacts.
- Negative FDA-approved HIV test.
- Available and willing to participate in follow-up visits and tests for the duration of the study.
- Willing to have samples stored for future research. The following apply to vaccinees and intimate contacts, but not to household contacts:
- In good general health without clinically significant medical history.
- Assessed as low risk for HIV infection by agreeing to discuss HIV infection risks with the study clinicians, agreeing to HIV risk reduction counseling, and agreeing to avoid behavior associated with high risk of HIV...
- Negative beta-HCG pregnancy test for females presumed to be of reproductive potential.
- Female vaccinees and male intimate contacts must meet one of the following criteria: -The female vaccinee has no reproductive potential because of menopause (1 year without menses) or because of a hysterectomy...
- condoms, male or female, with a spermicide.
- diaphragm or cervical cap with spermicide.
- contraceptive pills, Norplant, or Depo-Provera (and is not on any medications that would interfere with the how well it works of these contraceptive agents).
- male partner has previously undergone a vasectomy for which there is documentation.
- intrauterine device.
- Male vaccinees and female intimate contacts must agree to consistently practice abstinence or effective birth control (described above) and for 21 days following each vaccination. The following apply only to vaccinees...
- Willing to receive HIV test results and abide by NIH guidelines for partner notification of positive HIV results.
- Physical examination and laboratory results without clinically significant findings within the 8 weeks prior to enrollment.
- Willing to avoid other investigational and/or HIV vaccinations, other than the study agent, from screening through the end-of-study visit.
- Safety laboratory criteria within 8 weeks prior to enrollment:
- Hematologic:
- White blood cell count and lymphocyte count within 25% of both the lower limit and upper limit of normal for the NIH CC
- Platelet count of least 150,000/mm\^3.
- Hemoglobin count within 10% of both the lower limit and upper limit of normal for the NIH CC
- Renal: Blood urea nitrogen (BUN) \<23 mg/dL; creatinine within normal limits for the NIH CC
- Hepatic: Serum direct bilirubin within normal limits for the NIH CC
- Metabolic: Alanine aminotransferase (ALT) \<2 times upper limit of normal range for the NIH CC
- Additional laboratory criteria:
- Immunologic: No history of hypogammaglobulinemia.
- Serologic: Ad4 neutralizing antibody 80% inhibitory dilution \<1:100. (This criterion does not apply to participants in Arm B.)
- Willing to follow precautions for preventing the spread of adenovirus in the community.
- Males must agree not to donate sperm for 21 days following each study vaccination.
What rules you out
- A participant (vaccinees, household contacts, and intimate contacts) will be excluded if they have the following: 1\. Any condition that, in the investigator's judgement, places the subject at undue risk by...
- History of any prior disease or therapy which would affect immune or pulmonary function.
- Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of radiation therapy or cytotoxic/cancer chemotherapy.
- History of uncontrolled diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c \<= 8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary...
- Immunodeficiency or autoimmune disease.
- Acute infection or a recent history (within 6 months) of chronic infection suggestive of immunodeficiency.
- Taking any glucocorticoids or other immunosuppressive medications.
- Asthma is excluded if the participant has ANY of the following:
- Required either oral or parenteral corticosteroids for an exacerbation 2 or more times within the past year, OR
- Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought...
- Uses a short-acting rescue inhaler more than 2 days/week for acute asthma symptoms (i.e., not for preventive treatment prior to athletic activity); OR
- Uses medium-to-high-dose inhaled corticosteroids (greater than 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (i.e., with a long-acting beta agonist), OR
- Uses more than 1 medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than 1 medication for maintenance therapy daily for greater than 2 years requires OCRPRO Clinical Safety Office...
- Other chronic respiratory disorders including emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent or ongoing respiratory tract infection. If a respiratory disorder is transient...
- Female of childbearing potential who is breast-feeding or planning pregnancy during the period from enrollment through 21 days following the last study vaccination. The following exclusion criteria apply only to...
- Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to receipt of live virus vaccine...
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years...
- Individuals that live in the same house or apartment with any of the following will be excluded:
- An individual under 18 years of age.
- An elderly individual (\>65 years of age).
- An immunocompromised or immunosuppressed individual.
- An individual with chronic respiratory disease.
- A woman who is currently pregnant or breastfeeding or planning a pregnancy during the period of vaccination.
- Individuals who provide hands-on care to immunodeficient, unstable, elderly, or children \<18 years of age within 21 days following each of the first and second vaccination timepoints.
- Receipt of any of the following:
- Antiviral medications within 30 days prior to vaccination.
- Blood products within 120 days prior to HIV screening.
- Immunoglobulin within 60 days prior to HIV screening.
- Investigational research drugs or any other investigational agent that in the judgement of the Principal Investigator might interact with the study vaccine within 30 days prior to initial study vaccine administration.
- Allergy treatment with antigen injections within 30 days of study vaccine administration.
- Active hepatitis B or C infection (i.e., hepatitis B or C positive serology with the presence of virus antigen or DNA). Ongoing viral replication will be confirmed by a hepatitis B antigen test or hepatitis C viral load.
- History of Guillain-Barre syndrome.
- Indeterminate HIV Western blot test.
- Prior receipt of the Merck Ad5-based HIV vaccine.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.