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Gonorrhea Treatments

Gonorrhea Treatments 2024

Gonorrhea can be treated with antibiotics; however, the bacteria have developed resistance to some treatments, and treatment will not repair any permanent damage done by the disease, says the U.S. Centers for Disease Control and Prevention (CDC). The WHO announced on July 24, 2023, that the spread of a Neisseria gonorrhea clone highly resistant to ceftriaxone is increasingly being reported in various countries. 

Gonorrhea Treatment Candidates

GSK plc announced on April 17, 2024, positive headline results from the pivotal EAGLE-1 phase III trial for gepotidacin (GSK2140944). Gepotidacin achieved a 92.6% microbiological success rate and was non-inferior to the leading combination treatment. Gepotidacin is an investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a novel mechanism of action and binding site and, for most pathogens, provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most strains of target uropathogens (such as E. coli and S. saprophyticus) and N. gonorrhoeae, including isolates resistant to several antibiotics. Due to the well-balanced inhibition of two enzymes, gepotidacin target-specific mutations are needed to affect gepotidacin susceptibility significantly. EAGLE-2 and EAGLE-3 were phase 3 studies that found that Gepotidacin is an efficacious oral antibiotic with acceptable safety and tolerability profiles.

On November 1, 2023, the journal Nature published an article: The potential new super gonorrhea treatment, called zoliflodacin, developed initially by drug firm AstraZeneca and later by its spin-off Entasis Therapeutics, targets an essential bacterial enzyme that untangles DNA during cell replication. Zoliflodacin has a unique mechanism of action that inhibits a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction.

The NEJM journal published Original Research on April 6, 2023, which found that gonorrhea incidence was low with doxycycline postexposure prophylaxis. The Lancet Infectious Disease wrote on June 12, 2023, that there is increasing evidence that doxycycline post-exposure prophylaxis (doxy-PEP) effectively prevents sexually transmitted infections among high-risk patients, particularly in patients using HIV preexposure prophylaxis. Overall, the risk of selecting dual-resistant strains and increasing N gonorrhea ceftriaxone resistance must be carefully balanced against the benefits of using doxy-PEP to prevent and treat sexually transmitted infections. The randomized phase of the DOXYVAC clinical study was stopped in August 2022 when DoxyPEP, a U.S. study presented at the International AIDS Conference, found that doxycycline PEP cut the risk of gonorrhea by 55%. In California, doxy-PEP is recommended for certain people.

Gonorrhea Tests

CARB-X announced on April 18, 2024, that it will award up to $1 million to diagnostics and health tech company Scout to demonstrate proof-of-concept and feasibility ahead of developing a new point-of-care test, STI Scout. The test will detect and differentiate between Neisseria gonorrhoeae and Chlamydia trachomatis.

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Robert Carlson, MD
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Friday, April 19, 2024 - 10:45
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Gonorrhea Treatments are available in 2024
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Gonorrhea
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According to the U.S. CDC Yellow Book 2024, an international traveler's risk for acquiring Yellow Fever virus is determined by their immunization status and destination-specific and travel-associated factors. 

Since about thirty countries require proof of a pre-arrival yellow fever vaccination, many travelers have questions about the vaccine's long-term efficacy.

On January 22, 2024, the Lancet Global Health recently published results from a systematic review aimed at assessing the necessity of a booster vaccination based on the long-term (10+ years) immunogenicity of primary yellow fever vaccination in travelers and in residents of yellow fever-endemic areas, as well as in specific populations, including children and immunocompromised individuals.

The gathered evidence suggested that a single dose of yellow fever vaccine provides lifelong protection (overall seroprotection rate 94%) in travelers.

However, in people living with HIV and young children (<2 years), booster doses might still be required because lower proportions of vaccinees were seroprotected ten or more years post-vaccination.

The pooled seroprotection rate was 47% in children and 61% in people living with HIV. 

Lower observed seroprotection rates among residents of yellow fever endemic areas were partly explained by the use of a higher cutoff for seroprotection that was applied in Brazil. No conclusions could be drawn for the sub-Saharan Africa region.

The CDC says most people infected with yellow fever do not get sick or have only mild symptoms. People who get sick will start having symptoms 3–6 days after infection.

According to the CDC, about 12% of people with symptoms develop serious illnesses.

The study was registered with PROSPERO, CRD42023384087. No industry conflicts of interest were disclosed.

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Yellow Fever
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US CDC Yellow Book 2024
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Don Hackett
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Austin
Vaccine: 
YF-VAX Yellow Fever Vaccine
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measles

Confirming Measles Outbreaks By Wastewater Testing in 2024

Wastewater surveillance can identify measles and polio viruses.
January 29, 2024
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As the world awaits the approval of a Human Immunodeficiency Virus (HIV) vaccine, a novel candidate based on Gorilla adenoviral vector (GRAd-HIV) technology was recently funded by The Bill & Melinda Gates Foundation.

Over the past few decades, various HIV vaccine candidates have not succeeded in human clinical trials.

Announced on January 22, 2024, ReiThera Srl, the Ragon Institute of Mass General, MIT, Harvard, and IAVI confirmed a collaboration to develop a novel HIV vaccine candidate that will be composed of ReiThera’s GRAd vector and HIV T-cell epitopes.

ReiThera’s vaccine platform uses a novel proprietary GRAd vector belonging to species C adenoviruses that are considered among the most potent vaccine carriers for the induction of CD8 T-cell responses to the encoded antigens and having a low seroprevalence in humans.

Prior findings by the Ragon Institute have shown that mutation of residues at important network positions disproportionately impaired viral replication and occurred with high frequency in epitopes presented by protective human leukocyte antigen (HLA) class I alleles.

Moreover, CD8+ T-cell targeting of highly networked epitopes distinguished individuals who naturally control HIV, even in the absence of protective HLA alleles.

“We are thrilled to have the opportunity to collaborate with ReiThera and IAVI, with the support of the Bill & Melinda Gates Foundation, to advance the GRAd-HIV highly networked T-cell vaccine candidate towards clinical evaluation,” said Gaurav Gaiha, Ragon faculty member, in a press release.

“We are particularly pleased that this takes place with partners in sub-Saharan Africa, given the immense need for new solutions to curtail the ongoing HIV epidemic.”

Key partners in this program include researchers at the Africa Health Research Institute, the National Institute for Communicable Diseases in South Africa, Mutala Trust, and Charles River Medical Group in Zimbabwe.

IAVI is the sponsor and will execute a phase I clinical trial.

Vaccine Treats: 
HIV
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by Jodie Donahoo
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Karen McClorey Hackett
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Rome
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Tuberculosis cases

Is the U.S. CDC Expecting a Tuberculosis Outbreak

Tuberculosis vaccines are globally available in 2024
January 18, 2024
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Novotech recently released the latest global clinical trial landscape report on HIV, a condition now affecting more than 39 million people.

According to the HIV Global Clinical Trial Landscape report published on December 18, 2023, the biopharma industry has initiated over 1,000 HIV clinical trials worldwide since 2018.

The distribution of the trials is as follows: Asia-Pacific accounts for 29% of trials, Europe at 28%, and North America at 26%, while the Rest of the World contributes a moderate share of 17%.

The report delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.

It begins by elucidating HIV's progression, from its attack on the immune system to the potential development of AIDS. In the United States, there were 1.2 million HIV cases, leading to 19,986 deaths in 2022.

At the report's core lies the worldwide strategy articulated by organizations such as WHO, the Global Fund, and UNAIDS to eradicate the HIV epidemic by 2030.

Moreover, the report explores cutting-edge research, including long-acting injectables, HIV vaccines, and gene editing, underscoring the potential to find an HIV cure.

As of December 31, 2023, there are no approved HIV vaccines available, but several vaccine candidates are conducting studies.

Novotech's research analyst team provides these expert reports every month, free of charge.

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HIV
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by Gerd Altmann
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Karen McClorey Hackett
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Boston
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HIV Vaccines
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The World Health Organization (WHO) recently published its External Situation Report #31 regarding the ongoing, multi-country outbreak of mpox.

Based on the data reported on December 22, 2023, the mpox outbreak continues in most WHO regions, while more extensive transmission has been observed in the European Region and the Region of the Americas.

A total of 906 additional mpox cases were reported in November 2023, representing a 26% increase compared to October.

The United States of America (299 vs. 135) reported the most significant increase in the Americas. The states of California, New York, and Texas have reported the most mpox cases.

Around half (52%) of cases with available information in this outbreak are reported to be in persons living with HIV. 

The U.S. CDC's Advisory Committee on Immunization Practices voted on October 25, 2023, to recommend the routine use of the JYNNEOS® vaccine for people at risk of mpox infection.

However, only 23% of the at-risk population has been fully vaccinated nationally as of December 2023.

On December 7, 2023, the CDC published an advisory stating the JYNNEOS is expected to be effective for both Clade I and Clade II MPXV infections. However, real-world data is lacking, reported the European CDC.

According to the CDC, approximately 1.2 million JYNNEOS vaccine doses have been administered in the U.S. since the mpox outbreak began in May 2022.

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mpox
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US CDC mpox case map Dec. 2023
Live Blog Update Author: 
Don Hackett
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Geneva
Vaccine: 
JYNNEOS Smallpox Mpox Vaccine
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Following the discovery of Human Immunodeficiency Virus (HIV) as a causative agent of AIDS, multiple vaccine-candidate clinical trials have been conducted over the past 35 years. 

According to the authors of a new study published in the journal Science, future HIV vaccine candidates may be more successful if they include additional doses or persist longer in the body to stimulate the immune system further.

These researchers wrote on December 14, 2023, that the potential of an HIV vaccine might be better judged by measuring how it affects CD8+ T-cell function and sensitivity in addition to just assessing the number of CD8+ T cells generated, which has been the usual practice. 

These findings build on decades of research by the HIV-Specific Immunity Section of NIAID’s Laboratory of Immunoregulation to better understand the immune response to HIV.

The insights from this study may help guide future preventive and therapeutic HIV vaccine design and development and HIV immunotherapy approaches. 

Mark Connors, M.D., chief of the HIV-Specific Immunity Section of NIAID’s Laboratory of Immunoregulation, is available to discuss this research via e-mail at [email protected].

As of December 23, 2023, there are no approved HIV vaccines.

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HIV
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US NIH 2023
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Karen McClorey Hackett
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Bethesda
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HIV Vaccines
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HOOKIPA Pharma Inc. today announced that Gilead Sciences has purchased 15 million shares of the company's common stock for approximately $21.25 million, for $1.4167 per share.

This transaction closed on December 20, 2023, indicating Gilead's total ownership in HOOKIPA's Common Stock is approximately 19.4%.

In addition, HOOKIPA has other transaction rights.

Joern Aldag, Chief Executive Officer at HOOKIPA, commented in a press release on December 21, 2023. "Together, we have made meaningful progress in finding a potential functional cure for Human Immunodeficiency Virus (HIV)."

"Most recently, we received clearance from the U.S. Food and Drug Administration of our Investigational New Drug application for HB-500 and are excited to begin our Phase 1 trial in the first half of 2024."

HB-500 is an alternating, 2-vector arenaviral therapeutic vaccine that is being evaluated as part of a potential curative regimen for HIV.

One vector is based on lymphocytic choriomeningitis virus as its arenaviral backbone; another vector is based on the Pichinde virus.

Both encode the same HIV antigens.

HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial. Gilead has the exclusive right to assume further development of the program thereafter.

As of December 22, 2023, there are several HIV vaccine candidates conducting research, but none have been approved. According to the U.S. National Institutes of Health, HIV vaccine candidates can not cause an HIV infection.

Vaccine Treats: 
HIV
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by Tumisu
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Don Hackett
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New York
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HIV Vaccines
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Uvax Bio, LLC today announced acknowledgment from the Australian Therapeutic Goods Administration and approval from the Human Research Ethics Committee (HREC) to conduct a Phase 1 study of Uvax Bio's HIV-1 vaccine candidates in Australia.

The two vaccines being tested are based on Uvax Bio's proprietary 1c-SApNP® technology, displaying 20 uncleaved, prefusion-optimized (UFO) HIV envelope (Env) trimers in wild-type and glycan-trimmed forms (UVAX-1197 and UVAX-1107, respectively).

Uvax Bio's HIV-1 vaccines are combined with Dynavax's CpG 1018® adjuvant and aluminum hydroxide.

Uvax Bio will work with their Australia-based clinical research partners Avance Clinical and the Nucleus Network study site to initiate this study in January 2024.

Previously, in a preclinical toxicology study, UVAX-1107 & 1197 combined with CpG 1018® and aluminum hydroxide were safe with no serious adverse events.

In a second preclinical immunogenicity study, immunization with Uvax Bio's HIV-1 vaccine candidates elicited robust neutralizing antibody responses against the vaccine-matched virus in 99% of the animals.

Furthermore, preliminary screening assays demonstrated appreciable neutralization in serum when tested against a panel of primary HIV-1 isolates.

"The body of evidence from our preclinical studies and GMP manufacturing runs was instrumental in facilitating this authorization to begin preparation for our first Phase 1 trial," commented Ji Li, Ph.D., Uvax Bio CEO, in a press release on December 19, 2023.

"Our clinical team will begin preparing to initiate this trial in January 2024."

As of December 20, 2023, the U.S. Food and Drug Administration, Japan's National Institute of Infectious Diseases, the European Medicines Agency, and the United Kingdom had not approved an HIV prevention vaccine.

Vaccine Treats: 
HIV
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from Pixabay
Live Blog Update Author: 
Don Hackett
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Delaware
Vaccine: 
HIV Vaccines 2023