Vaccines for HIV Soon-To-Be Available

A news story from the Daily Telegraph reported that apparently, a vaccine could minimize HIV to a “minor infection”. According to the story, a phase I clinical trial was done to evaluate the safety of the fresh HIV vaccine in a minor group of individuals in Spain.

The researchers hired 30 people who were without HIV and injected 24 of them with the latest HIV vaccine, which was actually based on a smallpox vaccine. The rest, 6 people, got only placebo injections. The researchers observed these people for 48 weeks.

The researchers learned that the vaccine seemed to be tolerated well at this point in time, with no grave side effects. Above three-quarters of the volunteers were seen with a noticeable immune reaction to the vaccine. But the main goal of this introductory study was to evaluate safety and not efficacy. It is yet unknown whether or not the immune reaction caused by the vaccine will be enough to guard against HIV infection or to decrease HIV amounts in those who are HIV positive already. It is possible that more safety tests in a bigger group of people will be done prior to the assessment of the vaccine’s effectiveness.

The research was done by researchers from The Hospital Clinic – IDIBAPS, Barcelona, Spain, the CentroNacional de Biotecnologia, CSIC, Madrid, Spain, and some other Swedish, Spanish, British and Swiss research institutes. It was financially supported by FIPSE, HIVACAT, and FIS, all Spanish research foundations.

The study came out in the peer-reviewed journal Vaccine.

The study was well-discussed by The Daily Telegraph, the Daily Mirror, and the Daily Mail – all three stated that future tests will have to be done. The Daily Telegraph gave details on what the researchers had stated the following steps would be.

This was a phase I clinical trial to evaluate how safe an HIV/AIDS vaccine is and how well it might aggravate an immune reaction (a sign that a vaccine is bringing about an effect). Phase I studies are ones that usually check the introductory safety of a treatment in a tiny group of individuals. These kinds of studies usually don’t have a control group. In this instance, 24 people got the vaccine while 6 got the placebo. It is important to note that this kind of trial is not created to test efficacy and the researchers were not attempting to evaluate how well the vaccine keeps people from getting HIV.  But they did examine the strength of the immune reaction to the vaccine. Immune response is a marker for concluding triumph of the vaccine and a signal that the vaccine is achieving an effect.

The vaccine was founded on a smallpox vaccine that was modified with HIV genes. It was called MVA-B. The plan was that the vaccine would prepare the body to familiarize HIV so that it could rise to a quick immune response. This would possibly let the body clear the HIV to amounts that don’t bring about disease, if used for treatment of those who have already HIV. If used as prevention from acquiring HIV, hopefully it would keep the virus from getting into cells to begin with.

The study was done in Spain. The researchers hired 30 men and women who didn’t have HIV and had small threat of infection. The people were among 18 and 55 years old, and 24 of them were men. The people do not have a history of former smallpox vaccination. The researchers assigned at random 6 people to get placebo and 24 people to get the vaccine.

The 24 individuals got three injections of the vaccine in their muscle, and the control group got placebo injections. The two groups got the injections at the beginning of the study, four weeks after, and 16 weeks after. The individuals were then observed for 48 weeks.

The individuals were requested to use an effective contraceptive method with their partner 14 days before their initial vaccination until 4 months following the last one.

The main endpoints (the measures regarded by the researchers as the most significant) were grave side effects and how fit the body built up an immune response. They particularly examined at a T-cell, a kind of immune cell. The researchers also considered less serious side effects and how fine the body created antibodies against the vaccine.

Assessing side effects was done all through the research. Blood tests were done at the beginning of the study and during the 4th, 8th, 16th, 20th, and 48th weeks. The individuals were supplied with safe sex guidance and an HIV test during the screening interview and at the 4th, 16th, and 48th weeks.

The researchers stated that the vaccine was tolerated well in general. 169 adverse incidents were claimed during follow-up: 5 were grade-3 adverse incidents, which would be deemed serious. But, despite the 5 grave adverse incidents being in the vaccination group, these were not regarded as connected to the study drug. For instance, a volunteer had tonsillitis, another had a traffic accident, while another had pneumonia as well as 2 asthma attacks. Of the 145 claimed less severe adverse incidents (grade 1 and 2), 52 were regarded to be surely connected to the vaccination. The most frequent mild adverse incidents included headaches and pain at the injection site.

The researchers learned that positive T-cell immune reactions were identified in 75% of the individuals and that these were preserved until the 48th week in 68% of the individuals. The ratio of responders enlarged following the second dose. 95% of the individuals developed antibodies against the vaccine at the 18th week and 72% developed antibodies at the 48th week.

The researchers state that in this initial phase I trial with the HIV/AIDS vaccine contender MVA-B in healthy individuals the vaccine was harmless and tolerated well and brought out durable and strong T-cell reactions in 75% of the participants. They state that their facts sustain extra examination of MVA-B as an HIV vaccine contender.

The phase I trial exhibited that this HIV vaccine was tolerated well and did not reach grave adverse reactions in few healthy participants. The vaccine was also revealed to bring about a T-cell immune reaction in 75% of the 24 individuals and to result in antibody reactions in 95%.

The outcomes are heartening and will likely denote that the researchers continue to examine safety as well as immune reaction to this vaccine in a bigger group of people. There are two likely ways the vaccines could be utilized to battle HIV. A vaccine could be used either as a prophylaxis to keep people from being infected with the vaccine, or as a treatment used to help the body diminish the HIV amounts once a person is HIV positive already. The goal of therapeutic use would be to lower symptoms of the disease.

This study did not examine at the efficacy of the vaccine, as well as how well it can provide protection against HIV infection or decrease HIV amounts in the body of those who are already infected.

Additional study is required to check the vaccine in these two fields – prevention of HIV infection or reduction of the amount of virus particles in those who are infected. Also, several other research are examining at possible HIV vaccines, and the study will be required to check how well this vaccine measure up to these.

 

Image courtesy of nicornbooty.com

Daisy Jane Antipuesto RN MN

Currently a Nursing Local Board Examination Reviewer. Subjects handled are Pediatric, Obstetric and Psychiatric Nursing. Previous work experiences include: Clinical instructor/lecturer, clinical coordinator (Level II), caregiver instructor/lecturer, NC2 examination reviewer and staff/clinic nurse. Areas of specialization: Emergency room, Orthopedic Ward and Delivery Room. Also an IELTS passer.

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