Archive for June 5, 2014

Sexually transmitted infections – Controversies and conundrums in screening, treatment and stigma

Current Opinion in Infect. Dis  Feb 2014  V.27  N.1 P.53–55

Rogstad, Karen

Sheffield Teaching Hospitals NHS Foundation Trust and Undergraduate Dean, University of Sheffield Medical School, Sheffield, UK

Correspondence to Karen Rogstad, Consultant in HIV and Sexual Health, Sheffield Teaching Hospitals, NHS Foundation Trust and Undergraduate Dean, University of Sheffield School of Medicine, Royal Hallamshire Hospital, Glossop Road, Sheffield S10 2JF, UK. Tel: +44 114 271 1900; e-mail: Karen.rogstad@sth.nhs.uk

The five review topics in this issue highlight some of the key controversies in sexually transmitted infections (STIs), and their control.

The authors are from all corners of the world and work in different healthcare systems, but all have an awareness of the internationality of STIs, which do not conform to national boundaries.

A problem in one country can rapidly spread to other continents, requiring a world view of STI treatment and control, and international collaboration and support.

There are some major areas of concern: in men who have sex with men (MSM), there is a resurgent syphilis epidemic, hepatitis C in HIV-positive men has an annual incidence of transmission of 2–4% [1], and there is no decrease in HIV incidence in MSM; gonorrhoea has increased globally by 21% over 3 years [2] and multidrug, extensively drug-resistant and potentially untreatable

FULL TEXT

http://journals.lww.com/co-infectiousdiseases/Fulltext/2014/02000/Sexually_transmitted_infections___controversies.8.aspx

PDF (CLIC on PDF)

 

June 5, 2014 at 8:39 am

Efficacy of Pneumococcal Nontypable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) in Young Latin American Children: A Double-Blind Randomized Controlled Trial

PLOS Medicine June 2014

Miguel W. Tregnaghi,  Xavier Sáez-Llorens, Pio López, Hector Abate, Enrique Smith, Adriana Pósleman, Arlene Calvo,

Digna Wong, Carlos Cortes-Barbosa, Ana Ceballos, Marcelo Tregnaghi, Alexandra Sierra, Mirna Rodriguez …

Background

The relationship between pneumococcal conjugate vaccine–induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear.

This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on these end points.

The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed.

Methods and Findings

This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care.

Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at booster) at 2, 4, 6, and 15–18 mo of age. Interim analysis of the primary end point was planned when 535 first B-CAP episodes, occurring ≥2 wk after dose 3, were identified in the per-protocol cohort.

After a mean follow-up of 23 mo (PHiD-CV, n = 10,295; control, n = 10,201), per-protocol VE was 22.0% (95% CI: 7.7, 34.2; one-sided p = 0.002) against B-CAP (conclusive for primary objective) and 25.7% (95% CI: 8.4%, 39.6%) against World Health Organization–defined consolidated CAP. Intent-to-treat VE was 18.2% (95% CI: 5.5%, 29.1%) against B-CAP and 23.4% (95% CI: 8.8%, 35.7%) against consolidated CAP.

End-of-study per-protocol analyses were performed after a mean follow-up of 28–30 mo for CAP and invasive pneumococcal disease (IPD) (PHiD-CV, n = 10,211; control, n = 10,140) and AOM (n = 3,010 and 2,979, respectively). Per-protocol VE was 16.1% (95% CI: −1.1%, 30.4%; one-sided p = 0.032) against clinically confirmed AOM, 67.1% (95% CI: 17.0%, 86.9%) against vaccine serotype clinically confirmed AOM, 100% (95% CI: 74.3%, 100%) against vaccine serotype IPD, and 65.0% (95% CI: 11.1%, 86.2%) against any IPD.

Results were consistent between intent-to-treat and per-protocol analyses. Serious adverse events were reported for 21.5% (95% CI: 20.7%, 22.2%) and 22.6% (95% CI: 21.9%, 23.4%) of PHiD-CV and control recipients, respectively.

There were 19 deaths (n = 11,798; 0.16%) in the PHiD-CV group and 26 deaths (n = 11,799; 0.22%) in the control group. A significant study limitation was the lower than expected number of captured AOM cases.

Conclusions

Efficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice.

Trial registration – http://www.ClinicalTrials.gov  NCT00466947

FULL TEXT

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001657

PDF

http://www.plosmedicine.org/article/fetchObject.action?uri=info%3Adoi%2F10.1371%2Fjournal.pmed.1001657&representation=PDF

June 5, 2014 at 8:36 am


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