WASHINGTON: A clinical trial testing freeze-dried, temperature-stable experimental tuberculosis (TB). vaccine it has been found to be safe in healthy adults and stimulates antibodies and responses from the cellular arm of the immune system, according to a new study.
The Phase 1 trial was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
A candidate non-temperature-stable form has previously been tested several times clinical trials.
However, this was the first clinical trial of any TB subunit vaccine candidate in a temperature-stable (thermo-stable) form, says the study.
The results of the study were published in the journal Nature Communications.
Experimental vaccine ID93+GLA-SE, Christopher B. Developed by scientists at Fox and the former Institute of Infectious Diseases Access Institute in Seattle, US.
According to the study, it is a recombinant subunit vaccine combined with GLA-SE, an immune-stimulating adjuvant, from four proteins of Mycobacterium tuberculosis bacteria.
The freeze-dried formulation does not require refrigeration and is mixed with sterile water prior to injection, the study said.
Thermostable vaccines are needed in situations where it is expensive and difficult to maintain cold or frozen vaccines for long periods of time.
The current trial investigated whether administration of a heat-stable vaccine containing both ID93 and GLA-SE in one vial would be as effective in inducing an immune response as a regimen containing two vials of non-thermostable ID93 and liquid GLA-SE. combined before injection.
A single vial presentation of a thermostable vaccine would have clear advantages in ease of storage, transportation and administration, the investigators noted.
Daniel F. Hoft, MD, director of the Vaccine Development Center at Saint Louis University, led the single-site trial at the university’s School of Medicine.
Twenty-three participants received the thermostable single-vial regimen, and 22 participants received the two-vial, non-thermostable regimen.
Both vaccines were safe and well tolerated.
Those who received the one-vial thermostable vaccine had robust T-cell responses and produced higher levels of antibodies in the blood than those who received two vials of the non-thermostable vaccine.
Investigators noted some limitations in this small trial.
For example, no established correlates of protection determine which immune responses are required for vaccine-induced protection against tuberculosis.
Therefore, the enhanced immune responses observed in the thermostable vaccine formulation cannot be said to increase the protective efficacy of the vaccine.
Nevertheless, they concluded that the results of this trial were “proof of concept that adjuvanted vaccines can be offered in a single freeze-dried vial without detrimental effects on clinical immunogenicity or safety characteristics.”
The Phase 1 trial was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
A candidate non-temperature-stable form has previously been tested several times clinical trials.
However, this was the first clinical trial of any TB subunit vaccine candidate in a temperature-stable (thermo-stable) form, says the study.
The results of the study were published in the journal Nature Communications.
Experimental vaccine ID93+GLA-SE, Christopher B. Developed by scientists at Fox and the former Institute of Infectious Diseases Access Institute in Seattle, US.
According to the study, it is a recombinant subunit vaccine combined with GLA-SE, an immune-stimulating adjuvant, from four proteins of Mycobacterium tuberculosis bacteria.
The freeze-dried formulation does not require refrigeration and is mixed with sterile water prior to injection, the study said.
Thermostable vaccines are needed in situations where it is expensive and difficult to maintain cold or frozen vaccines for long periods of time.
The current trial investigated whether administration of a heat-stable vaccine containing both ID93 and GLA-SE in one vial would be as effective in inducing an immune response as a regimen containing two vials of non-thermostable ID93 and liquid GLA-SE. combined before injection.
A single vial presentation of a thermostable vaccine would have clear advantages in ease of storage, transportation and administration, the investigators noted.
Daniel F. Hoft, MD, director of the Vaccine Development Center at Saint Louis University, led the single-site trial at the university’s School of Medicine.
Twenty-three participants received the thermostable single-vial regimen, and 22 participants received the two-vial, non-thermostable regimen.
Both vaccines were safe and well tolerated.
Those who received the one-vial thermostable vaccine had robust T-cell responses and produced higher levels of antibodies in the blood than those who received two vials of the non-thermostable vaccine.
Investigators noted some limitations in this small trial.
For example, no established correlates of protection determine which immune responses are required for vaccine-induced protection against tuberculosis.
Therefore, the enhanced immune responses observed in the thermostable vaccine formulation cannot be said to increase the protective efficacy of the vaccine.
Nevertheless, they concluded that the results of this trial were “proof of concept that adjuvanted vaccines can be offered in a single freeze-dried vial without detrimental effects on clinical immunogenicity or safety characteristics.”
