Core-g28v2 60mer mRNA Vaccine for Hiv

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UT Health San Antonio, San Antonio, TX
Hiv
Core-g28v2 60mer mRNA Vaccine - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a vaccine made from a combination of two different mRNA vaccines can be safely given to people who are not infected with HIV.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Core-g28v2 60mer mRNA Vaccine will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Hiv. Measurement will happen over the course of 9 months.

10 months
Exploratory Immunogenicity
Immunogenicity
9 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Study Group 3
1 of 4
Study Group 2
1 of 4
Study Group 4
1 of 4
Study Group 1
1 of 4
Experimental Treatment

This trial requires 56 total participants across 4 different treatment groups

This trial involves 4 different treatments. Core-g28v2 60mer MRNA Vaccine is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Study Group 3eOD-GT8 60mer mRNA Vaccine (100µg) and Core-g28v2 60mer mRNA Vaccine (100µg)
Study Group 2eOD-GT8 60mer mRNA Vaccine (100µg) and Core-g28v2 60mer mRNA Vaccine (100µg)
Study Group 4
Biological
Core-g28v2 60mer mRNA Vaccine (100µg)
Study Group 1
Biological
eOD-GT8 60mer mRNA Vaccine (100µg)

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10 months for reporting.

Closest Location

UT Health San Antonio - San Antonio, TX

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Hormonal contraception, including contraceptive implant or injectable
Successful vasectomy in the male partner (considered successful if a woman reports that a male partner has documentation of azoospermia by microscopy [1 year ago], or a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy)
Healthy adults as assessed by a medical history, physical examination, and laboratory tests who are at least 18 years at the time of screening and less than 51 years at the time of first IP administration;
In the opinion of the Principal Investigator (PI) or designee and based on Assessment of (informed consent) Understanding (AOU) results, has understood the information provided and potential impact and/or risks linked to IP administration and participation in the study; written informed consent will be obtained from the participant before any study-related procedures are performed;
Willing to comply with the requirements of the protocol and be available for follow-up for the planned duration of the study;
Oral contraception
Diaphragm or cervical cap with spermicide
Condoms (male or female) with or without spermicide
Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results;
Intrauterine device

Patient Q&A Section

What are common treatments for hiv?

"Commonly prescribed treatment for HIV in Italy are antiretroviral drugs (mostly Nucleoside Reverse Transcriptase Inhibitor drugs) and prophylactic therapy. There is a lack of information in regards to therapy in Italy." - Anonymous Online Contributor

Unverified Answer

What is hiv?

"HIV is an illness caused by a virus and is a significant risk factor for many diseases. It is an illness that kills about 50 million people each year. Worldwide, more than 40 million people are living with HIV and about 2 million people are being new infected each year.\n" - Anonymous Online Contributor

Unverified Answer

How many people get hiv a year in the United States?

"Around 440,000 new HIV infections are confirmed each year in the United States. Although less than 10% of those diagnosed as HIV carriers become symptomatic, around 25% of those infected with HTLV-1 become symptomatic. While HIV treatment has led to significant reductions in AIDS-related mortality, new infections have not been reduced drastically and remain a major public health problem. The AIDS epidemic in America should be considered a slow wave to a more destructive pandemic. This paper is an attempt to explain how such a pandemic could occur, especially in a country with an effective health protection system like the United States." - Anonymous Online Contributor

Unverified Answer

What causes hiv?

"The majority of HIV infection worldwide can be attributed to three main routes of HIV transmission: sexual contact, injection of contaminated blood as intravenous drug use, and vertical transmission or mother-to-child transmission of HIV. In some countries, however, HIV infection disproportionately affects women, and certain non-Western groups of men. To understand what role biomedical HIV prevention research might play, we focus on the impact of these three routes on the overall risk of HIV transmission, and on specific risk factors that play a more role in transmission by one route than another. Understanding the role of these risk factors will help in developing policies and strategies to reduce HIV risk overall among individuals, populations, and communities." - Anonymous Online Contributor

Unverified Answer

Can hiv be cured?

"About 60% to 76% of hiv patients can be cured once the infection is detected. This is true even if the disease has progressed to a stage in its course at the time of treatment. A cure of hiv does not mean the total suppression of all signs and symptoms. The possibility of cure of the virus and of the disease must be evaluated together with the patient's individual treatment needs. With HAART the incidence of AIDS has decreased significantly, and thus patients diagnosed before the advent of HAART are less likely to present with advanced disease. Therefore, the majority of hiv patients could be cured by early, high-dose combination antiretroviral therapy." - Anonymous Online Contributor

Unverified Answer

What are the signs of hiv?

"Signs of HIV are fatigue, malaise and weight loss. Although it may be difficult to notice or to relate these features with the symptoms, awareness and prompt recognition and management of HIV can greatly improve the outlook for affected patients." - Anonymous Online Contributor

Unverified Answer

What does core-g28v2 60mer mrna vaccine usually treat?

"Results from a recent clinical trial showed that both core-g28v2 60mer and core-g28v3 60mer can induce immune response and show some limited antiviral activity in mice which can be explained by the core-g28v2 60mer 60mer sequence of the HCV genome. The immune response after vaccination with core-g28v2 60mer has some antiviral activity in mice after inoculation with HCV core-g28v2 60mer, but there is no effect after inoculation with HCV core-g28v3 60mer." - Anonymous Online Contributor

Unverified Answer

Does hiv run in families?

"This raises the disturbing possibility that the HIV in the German population may be run-in with a genetic propensity for the virus. Such a genetic predisposition could explain many previously unexplained and unexplainable patterns in the incidence of AIDS and may be potentially important for further investigations in related populations." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hiv?

"The average age someone gets hiv is 21.2 years. The majority of people getting in touch with this disease is between ages of 17 and 24 years. Many HIV positive persons fail to disclose their age when they get tested for HIV. This may be due to the fact that they feel bad about being labeled HIV positive. The older person gets diagnosed at, the more severe the illness is. This also indicates increased risk of death.\n" - Anonymous Online Contributor

Unverified Answer

Is core-g28v2 60mer mrna vaccine typically used in combination with any other treatments?

"The immune-response elicited by CAG-HIV60mer vaccination is likely improved by combination with a broad-spectrum adjuvant and a T-helper epitope. This vaccine may therefore be suitable for use in the context of future HIV-1 vaccination strategies." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hiv?

"The new drugs for treating HIV are more effective but are also far more dangerous than older medication. Because treatment is becoming more effective each year, it is possible that the chance of a cure will slip away. There are many factors involved, but a major one is that scientists and clinicians have far more information available about HIV than when they began their research. More information is available about treatment than about how HIV is transmitted and how it will be managed after treatment." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of core-g28v2 60mer mrna vaccine?

"The safety of the vaccine is acceptable after the review of the vaccination records of a large cohort of individuals. The most common side-effects in our population consisted with fever (>38.3 °C) in 11.2% of the vaccinated cohort. Drowsiness (0.6%) and nausea (>5%) occurred in 2.4% of the vaccinated cohort." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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