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1.
Georgian Med News ; (330): 99-105, 2022 Sep.
Article in English | MEDLINE | ID: mdl-36427851

ABSTRACT

Coronavirus disease 2019 (Covid-19) active cases continue to demand the development of safe and effective treatments. This is the first clinical trial to evaluate the safety and efficacy of oral thymic peptides. ; We conducted a nonrandomized phase 2 trial with a historic control group to evaluate the safety and efficacy of a daily 250-mg oral dose of thymic peptides in the treatment of hospitalized Covid-19 patients. Comparisons based on standard care from registry data were performed after propensity score matching. The primary outcomes were survival, time to recovery, and number of participants with treatment-related adverse events or side effects by day 20. ; A total of 44 patients were analyzed in this study: 22 in the thymic peptide group and 22 in the standard care group. There were no deaths in the intervention group compared to 24% mortality in standard care by day 20 (log-rank P=0.02). Kaplan-Meier analysis showed a significantly shorter time to recovery by day 20 in the thymic peptide group than in the standard care group (median, 6 days vs. 12 days; hazard ratio for recovery, 2.75 [95% confidence interval, 1.34 to 5.62]; log-rank P=0.002). No side effects or adverse events were reported. ; In patients hospitalized with Covid-19, the use of thymic peptides resulted in no side effects, adverse events, or deaths by day 20. Compared with the registry data, a significantly shorter time to recovery and mortality reduction were measured.


Subject(s)
COVID-19 Drug Treatment , Peptides , Humans , Honduras , Kaplan-Meier Estimate , Peptides/adverse effects , Proportional Hazards Models
2.
J Infect Dis ; 209(9): 1393-402, 2014 May 01.
Article in English | MEDLINE | ID: mdl-24520126

ABSTRACT

The Americas interrupted the transmission of poliovirus in 1991; most Latin American and Caribbean (LAC) countries rely on the oral polio vaccine (OPV) to maintain elimination. We estimated the risk of vaccine-associated paralytic polio (VAPP) in LAC for 1992-2011. VAPP cases were identified using LAC's acute flaccid paralysis (AFP) surveillance system. VAPP was defined as any AFP case with residual paralysis 60 days following onset that did not have a clear alternative etiology and with isolation of vaccine-strain poliovirus. Recipient VAPP cases were defined as those with paralysis onset 4-40 days following OPV; cases meeting these criteria but with unknown residual paralysis were added. Nonrecipient VAPP cases were defined as those in individuals with an unknown vaccination status, those in individuals who received 0 doses, or those with paralysis onset outside the 4-40-day interval. Of 40 926 AFP cases reported in LAC from 1992-2011, we identified 72 recipient and 119 nonrecipient VAPP cases. The estimated risk of recipient VAPP was 1 case per 3.15 million newborns (95% confidence interval [CI], 1 case per 2.56-4.10 million newborns), and the estimated overall risk was 1 case per 1.19 million newborns (95% CI, 1 case per 1.04-1.39 million newborns). In this multicountry VAPP analysis in a postelimination period, we found that the risk of VAPP in LAC was lower than previously estimated.


Subject(s)
Poliomyelitis/epidemiology , Poliovirus Vaccine, Oral/adverse effects , Caribbean Region/epidemiology , Child , Child, Preschool , Female , Humans , Infant , Latin America/epidemiology , Male , Poliomyelitis/etiology , Poliomyelitis/prevention & control , Poliovirus Vaccine, Oral/administration & dosage , Public Health Surveillance , Risk Assessment
3.
N Engl J Med ; 368(5): 416-24, 2013 Jan 31.
Article in English | MEDLINE | ID: mdl-23363495

ABSTRACT

BACKGROUND: To reduce the costs of maintaining a poliovirus immunization base in low-income areas, we assessed the extent of priming immune responses after the administration of inactivated poliovirus vaccine (IPV). METHODS: We compared the immunogenicity and reactogenicity of a fractional dose of IPV (one fifth of a full dose) administered intradermally with a full dose administered intramuscularly in Cuban infants at the ages of 4 and 8 months. Blood was collected from infants at the ages of 4 months, 8 months, 8 months 7 days, and 8 months 30 days to assess single-dose seroconversion, single-dose priming of immune responses, and two-dose seroconversion. Specimens were tested with a neutralization assay. RESULTS: A total of 320 infants underwent randomization, and 310 infants (96.9%) fulfilled the study requirements. In the group receiving the first fractional dose of IPV, seroconversion to poliovirus types 1, 2, and 3 occurred in 16.6%, 47.1%, and 14.7% of participants, respectively, as compared with 46.6%, 62.8%, and 32.0% in the group receiving the first full dose of IPV (P<0.008 for all comparisons). A priming immune response to poliovirus types 1, 2, and 3 occurred in 90.8%, 94.0%, and 89.6% of participants, respectively, in the group receiving the fractional dose as compared with 97.6%, 98.3%, and 98.1% in the group receiving the full dose (P=0.01 for the comparison with type 3). After the administration of the second dose of IPV in the group receiving fractional doses, cumulative two-dose seroconversion to poliovirus types 1, 2, and 3 occurred in 93.6%, 98.1%, and 93.0% of participants, respectively, as compared with 100.0%, 100.0%, and 99.4% in the group receiving the full dose (P<0.006 for the comparisons of types 1 and 3). The group receiving intradermal injections had the greatest number of adverse events, most of which were minor in intensity and none of which had serious consequences. CONCLUSIONS: This evaluation shows that vaccinating infants with a single fractional dose of IPV can induce priming and seroconversion in more than 90% of immunized infants. (Funded by the World Health Organization and the Pan American Health Organization; Australian New Zealand Clinical Trials Registry number, ACTRN12610001046099.).


Subject(s)
Antibodies, Viral/blood , Poliomyelitis/prevention & control , Poliovirus Vaccine, Inactivated/administration & dosage , Poliovirus/immunology , Cuba , Female , Humans , Immunization, Secondary , Infant , Injections, Intradermal , Injections, Intramuscular , Male , Poliomyelitis/immunology , Poliovirus Vaccine, Inactivated/adverse effects , Poliovirus Vaccine, Inactivated/immunology , Seroepidemiologic Studies
4.
Vaccine ; 18(7-8): 736-42, 1999 Nov 12.
Article in English | MEDLINE | ID: mdl-10547434

ABSTRACT

Hib conjugate vaccines are widely used in the industrialized world, but are just now beginning to be introduced into other countries. To identify factors facilitating rapid global introduction, we evaluated the decision-making process, mode of introduction, effectiveness, and impact on the immunization program of Hib conjugate vaccine introduction in four non- industrialized countries through site visits and use of a standardized questionnaire. The key promoters of Hib introduction were the pediatric community and ministries of health. Local surveillance and severity data were critical in the decision to adopt Hib vaccine. Assistance with surveillance, introduction guidelines, educational material, tenders, and funding is needed to accelerate wider adoption.


Subject(s)
Developing Countries , Haemophilus Vaccines/administration & dosage , Immunization Programs , Chile , Decision Making , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Global Health , Haemophilus Infections/prevention & control , Haemophilus influenzae/immunology , Humans , Infant , Infant, Newborn , Kuwait , Qatar , Uruguay , Vaccines, Conjugate/administration & dosage
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