Phase 1 Completed N=1 Prevention

Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus

Source: ClinicalTrials.gov NCT03618056 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2021

Primary outcomePrimary: Change in Response Rates of nAb Responses to the Vaccine Strains and a Global Panel of Heterologous Env-pseudotyped Viruses

Summary

The purpose of this study is to evaluate the breadth and potency of HIV-1 neutralizing antibody (nAb) responses and examine the safety and tolerability of an HIV gp120 protein vaccine (AIDSVAX® B/E) in HIV-uninfected adults diagnosed with Systemic Lupus Erythematosus (SLE) who have stable disease.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Response Rates of nAb Responses to the Vaccine Strains and a Global Panel of Heterologous Env-pseudotyped Viruses	—	—
PRIMARY Change in Magnitude of nAb Responses to the Vaccine Strains and a Global Panel of Heterologous Env-pseudotyped Viruses	—	—
PRIMARY Breadth of nAb Responses to the Vaccine Strains and a Global Panel of Heterologous Env-pseudotyped Viruses	—	—
PRIMARY Number of Participants With Local Reactogenicity Signs and Symptoms, Stratified by Severity	0; 1; 0; 0; 0; 0	—
PRIMARY Number of Participants With Systemic Reactogenicity Signs and Symptoms, Stratified by Severity	1; 0; 0; 0; 0; 1	—
PRIMARY Number of Participants With Adverse Events, by Relationship to the Study Product	0; 1; 0	—
PRIMARY Number of Participants With SLE Disease Activity and Functional Status Scores, by Score and Study Day	1; 1; 1; 1; 1; 1	—
SECONDARY Changes in Somatic Hypermutation in Participants With SLE Compared With Historical Controls	—	—
SECONDARY Change in Length of Antibody Binding Loops and Germline Gene Usage in Participants With SLE Compared With Historical Controls	—	—
SECONDARY Change in NAb Responses to Viruses With Altered Glycosylation, Indicative of bnAb Precursors	—	—
SECONDARY Change in Vaccine-induced Immune Activation	—	—
SECONDARY Change in Response Rate of HIV-1-Specific IgG Binding Antibodies	—	—
SECONDARY Change in Magnitude of HIV-1-Specific IgG Binding Antibodies	—	—
SECONDARY Change in Specificity of Antibody Responses	—	—
SECONDARY Change in Response Rate of Env-specific CD4+ T Cells	—	—
SECONDARY Change in Magnitude of Env-specific CD4+ T Cells	—	—
SECONDARY Change in Polyfunctionality of Env-specific CD4+ T Cells	—	—

Eligibility Criteria

Inclusion Criteria

General and Demographic Criteria

Age of 18 to 50 years
Weight greater than 110 pounds
Meets American College of Rheumatology (ACR) criteria for the classification of SLE with serologic evidence of disease including a positive test for antinuclear antibodies at a titer of 1:640 or greater, or the presence of a positive test for antibodies to double-strand DNA (dsDNA), or the presence of anti-Sm, anti-RNP, or anti-Ro antibodies, as documented by medical records and as assessed by a rheumatologist or designee.
Currently taking hydroxychloroquine for SLE and for at least 6 months prior to enrollment
Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
Ability and willingness to provide informed consent
Allows ongoing access to medical records pertaining to their rheumatologic disease
Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit

HIV-Related Criteria:

Willingness to receive HIV test results
Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit (see protocol for more information)

Laboratory Inclusion Values

Hemogram/Complete blood count (CBC)

Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 12.0 g/dL for volunteers who were assigned male sex at birth.
White blood cell count equal to 2,500 to 12,000 cells/mm^3
Total lymphocyte count greater than or equal to 800 cells/mm^3
Remaining differential either within institutional normal range or with site physician approval
Platelets equal to 100,000 to 550,000/mm^3

Chemistry

Chemistry panel: alanine amino transferase (ALT) and aspartate aminotransferase (AST) less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal.

Virology

Negative HIV-1 and -2 blood test: volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) within 56 days prior to enrollment.
Negative Hepatitis B surface antigen (HBsAg) within 56 days prior to enrollment
Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive within 56 days prior to enrollment

Urine

Normal urine by urinalysis:
Negative urine glucose, and
Negative or trace urine protein, and
Red blood cell (RBC) levels within institutional normal range, and
No RBC casts

Reproductive Status

Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test in accordance with local regulatory requirements, performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was assigned female sex at birth must:
Agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using the following methods:
Condoms (male or female) with or without a spermicide,
Diaphragm or cervical cap with spermicide,
Intrauterine device (IUD),
Hormonal contra

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03618056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.